September 29, 2023

Se

Fotona d.o.o.
Tina Bartolic
Quality Assurance and Regulatory Affairs
Stegne 7
Ljubljana, 1000, Slovenia

Re: K221274
Trade/Device Name: StarFormer, TightWave
Regulation Number: 21 CFR 21CFR 890.5850
Regulation Name: Powered muscle stimulator
Regulatory Class: Class II
Product Code: IPF, NGX
Dated: April 12, 2022
Received: May 2, 2022

Dear Tina Bartolic:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above
and have determined the device is substantially equivalent (for the indications for use stated in the enclosure)
to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment
date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the
provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket
approval application (PMA). You may, therefore, market the device, subject to the general controls
provisions of the Act. Although this letter refers to your product as a device, please be aware that some
cleared products may instead be combination products. The 510(k) Premarket Notification Database
available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.06.04
Silver Spring, MD 20993
www.fda.gov
K221274 - Tina Bartolic Page 2

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve
changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and
approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for
devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart
A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections
531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jitendra V. Virani -S
CDR Jitendra Virani, MS, MBA
Assistant Director
DHT5B: Division of Neuromodulation
and Physical Medicine Devices
OHT5: Office of Neurological
and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K221274

Device Name
StarFormer

Indications for Use (Describe)

Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy for the treatment of medical
diseases and conditions.
Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms
for rehabilitative purposes.
-Relaxation of muscle spasm,
-Prevention or retardation of disuse atrophy,
-Increasing local blood circulation,
-Muscle re-education,
-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
-Maintaining or increasing range of motion.

Fotona StarFormer is indicated for improvement of abdominal tone, for strengthening of the abdominal muscles, for
development of firmer abdomen
-Strengthening, Toning and Firming of buttocks and thighs

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
510k Summary
SUBMITTER'S INFORMATION

Submitter: Fotona d.o.o.

Stegne 7
1000 Ljubljana, Slovenia
Phone: +386 1 5009 100
Fax: + 386 1 5009 200

Contact Person: Tina Bartolic, Quality Assurance and Regulatory Affairs Specialist
Phone: + 386 1 5009 100
E-mail: tina.bartolic@fotona.com

Date: April 12, 2022

DEVICE INFORMATION
Device Trade Name: StarFormer
Common name: Magnetic Stimulator
Classification name: Stimulator, Muscle, Powered
21 CFR 890.5850, Class II
Product Code: IPF, NGX

PREDICATE DEVICES
- Neotonus MS-101 Magnetic Muscle Stimulator System (K973929)
- Johari Digital Healthcare Ltd., TORC BODY (K131291)

DEVICE DESCRIPTION SUMMARY

StarFormer is a non-invasive therapeutic device. The device comprises a magnetic stimulation coil
located in the applicator which is placed over the treatment area. During the treatment, an alternating
electric current is sent into the stimulation coil. The alternations in the electric current produce
electromagnetic field that interacts with the tissues of the human body. The device consists of a
system controller board which also drives the touchscreen and the GUI, a high voltage current power
supply and an applicator with electromagnetic coil.
 INDICATIONS FOR USE

Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy for the
treatment of medical diseases and conditions.
Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation
in the legs or arms for rehabilitative purposes.
-Relaxation of muscle spasm,
-Prevention or retardation of disuse atrophy,
-Increasing local blood circulation,
-Muscle re-education,
-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
-Maintaining or increasing range of motion.

Fotona StarFormer is indicated for

improvement of abdominal tone, for strengthening of the abdominal muscles, for development of
firmer abdomen
-Strengthening, Toning and Firming of buttocks and thighs

INDICATIONS FOR USE COMPARISON

The indications for use are based on previously cleared indications for the substantially
equivalent predicate devices, Neotonus MS-101 Magnetic Stimulator System (K973929) (primary
predicate) and Johari Digital Healthcare Ltd., TORC BODY (K131291) (second predicate).

TECHNOLOGICAL COMPARISON

A technical specifications comparison of StarFormer with predicate devices, Neotonus MS-101

Magnetic Stimulator System (K973929) (primary predicate) and Johari Digital Healthcare Ltd.,
TORC BODY (K131291) (second predicate), is presented in the table below.
Manufacturer Neotonus, Inc. Johari Digital Fotona d.o.o.
HealthCare Ltd.
Device name MS-101 Magnetic TORC BODY StarFormer
Muscle Stimulator SE determination
System

(Primary (Subject device)

(Second predicate)
predicate)
510 (k) number K973929 K131291 K221274
Indications for The Neotonus MS-101 TORC BODY is Fotona StarFormer is Same
use Magnetic Muscle indicated to be used for: intended to be used
Stimulator System is - Improvement of under medical
intended to be used under abdominal tone, for supervision for
medical supervision for strengthening of the adjunctive therapy for
adjunctive therapy for the abdominal muscles, for the treatment of medical
treatment of medical development of firmer diseases and conditions.
diseases and conditions. abdomen. Fotona StarFormer is
The Neotonus MS-101 - Strengthening, Toning indicated for use in
Magnetic Muscle and Firming of buttocks stimulating
Stimulator System is and thighs. neuromuscular tissue for
indicated for use in bulk muscle excitation in
stimulating neuromuscular the legs or arms for
tissue for bulk muscle rehabilitative purposes.
excitation in the legs or -Relaxation of muscle
arms for rehabilitative spasm,
purposes. -Prevention or
Indications for Use for retardation of disuse
Muscle Stimulators: atrophy,
-Relaxation of muscle -Increasing local blood
spasms circulation,
-Prevention or -Muscle re-education,
retardation of disuse -Immediate post-surgical
stimulation of calf
atrophy
muscles to prevent
-Increasing local blood venous thrombosis,
circulation -Maintaining or
-Muscle re-education increasing range of
-Immediate post-surgical motion.
stimulation of calf
Fotona StarFormer is
muscles to prevent
indicated for
venous thrombosis improvement of
-Maintaining or abdominal tone, for
increasing range of motion strengthening of the
abdominal muscles, for
development of firmer
abdomen
-Strengthening, Toning
and Firming of buttocks
and thighs
Primary function Muscle stimulation Muscle stimulation Muscle stimulation Same
Principle of Initiating action potential Initiating action Initiating action potential Same
action of nerves that results in potential of nerves that of nerves that results in
muscle contraction. results in muscle muscle contraction.
contraction.
Type of energy Magnetic field Electrical Magnetic field Same as primary
predicate, different
to second predicate,
but the difference
does not raise
 different questions
on safety and
effectiveness
therefore not
important for SE
determination.
Principal of action
is the same.
Product code Physical medicine Physical medicine Physical medicine Same
regulation 21 CFR 890.5850 21 CFR 890.5850 21 CFR 890.5850
IPF-Stimulator, Muscle, NGX-Stimulator, IPF-Stimulator, Muscle,
Powered Muscle, Powered, For Powered
Muscle Conditioning NGX-Stimulator, Muscle,
Powered, For Muscle
Conditioning
Pulse repetition 1-55 Hz 1-200 Hz 1-80 Hz No impact.
rate
The pulse
repetition rate of
StarFormer it is not
significantly
different from the
primary predicate.

Pulse repetition
rate of StarFormer
is witih the range
of the second
predicate.

The pulse
repetition rates of
StarFormer and
predicate devices
are in the typical
clinical range of
devices intended
for muscle
stimulation of up to
200 Hz (from
510(k) database).
Pulse duration 275 µs ± 20% 290 µs 330 µs No impact.

StarFormer`s pulse
duration is within the
range of the primary
predicate (± 20%).

StarFormer`s pulse
duration is not
significantly different
from the second
predicate (within 10%
range) and has no
significant impact on
safety and efficacy of
the device/therapy.
The pulse width of the
StarFormer device and
the predicate devices
are in the typical
clinical range
of 50 to 500μs.
Reference: “The effect
 of stimulus
current pulse width on
nerve fiber size
recruitment patterns”
by Robert B.
Szlavik and Hubert de
Bruin.

Pulse shape Symmetrical biphasic Symmetrical biphasic Symmetrical biphasic Same

Magnetic field Up to 2.2 T NA Up to 2.2 T Same
intensity
User interface Graphical Display Touch screen Touch screen Same
Number of 1 1 1 Same
Output Modes
Number of 1 2 1 Similar, but not
Output Channels significantly
different. This
information is not
relevant for SE
evaluation. The
number of output
channel is related
to the device type.
Software/ Yes Yes Yes Same
Firmware/
Microprocessor
Control
Timer Ranger Yes Yes Yes Same
ON Time 1 s to 30 s Not publicly available 1 s to 20 s Clinical outcome is
(device`s duty independent of
cycle) duty cycle.
OFF Time 0 s to 60 s Not publicly available 0 s to 240 s ON/OFF periods
(device`s duty are more related to
cycle) technological
limitations, namely
overheating of the
coil (OFF period).
Therefore, this
comparison is not
relevant for SE
evaluation.
Therapy Time 30, 60 min Up to 60 min Up to 30 min Similar.
Since the treatment
parameters are set
individually and
are based on a
patient pain
threshold, this
comparison is not
relevant for SE
evaluation.
Weight 28 kg / 50 kg Similar. Not
relevant for SE
evaluation since it
does not affect
safety and
effectiveness.
Dimenison 500 x 580 x 230 mm 200 x 150 x 100 mm 421 x 843 x 630 mm Similar. Not
[W x H x D] relevant for SE
evaluation since it
does not affect
safety and
 effectiveness.
Housing Not publicly available ABS body enclosure Device body is made of This information is
Materials and steel and plastic. not relevant for SE
Construction evaluation since no
Applicators are made of part of the
plastics. (subject) device
comes in the direct
contact with the
patient.

Technological differences between subject and predicate devices do not raise new type of safety
and effectiveness questions and are therefore deemed substantial equivalent.

NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY AND CONCLUSIONS

Non-Clinical Summary:

StarFormer has been evaluated via verification and validation tests for conformance to the
applicable regulations and safety standards. StarFormer is designed, tested, and will be
manufactured in accordance with following standards:
CB Scheme standards:
 IEC 60601-1:2005 + A1:2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance.
IEC 60601-1-2:2014
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential
performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
IEC 60601-1-6:2010 + A1:2013
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability.
IEC 62366-1:2015
Medical devices - Application of usability engineering to medical devices.
IEC 62304:2006 + A1:2015
Medical device Software – software life-cycle process.
ISO standards:
ISO 14971:2019
Medical devices — Application of risk management to medical devices

Clinical Summary:

No premarket clinical investigations were conducted since the performance of StarFormer is

based on the well-established magnetic stimulation technology and does not carry significant
residual risk for patients.

Conclusions:

StarFormer’s indications for use and technological characteristics do not raise new type of
questions regarding safety and efficacy when compared to b o t h predicates. Based on
technical characteristics, design, functional features, performance, and indications for use as
listed above, StarFormer is considered to be substantially equivalent to the selected predicate
devices.