Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a device that uses specific wavelengths of LED light for therapeutic purposes. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The performance studies focus on safety, electrical compatibility, and light output, not on algorithmic performance.

Therapeutic

Yes

The device explicitly states its intended use is to "treat periorbital wrinkles" and "treat mild to moderate inflammatory acne" using specified wavelengths of LED light, which are therapeutic applications.

Diagnostic

No

Explanation: The device is intended to treat periorbital wrinkles and mild to moderate inflammatory acne using LED light, which are therapeutic rather than diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as LED lights, a main control unit, attachment applicators, and an internal rechargeable battery. The performance studies also include testing related to electrical safety and photobiological safety, which are relevant to hardware devices.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The TheraFace LED device uses light irradiation (red, blue, and infrared) applied directly to the skin for therapeutic purposes (treating wrinkles and acne). It does not analyze any biological samples.
Intended Use: The stated intended uses are for treating specific skin conditions, not for diagnosing or monitoring a disease based on in vitro analysis.

The device is a therapeutic device that uses light energy applied externally to the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device can work in multiple function modes as following with different indication for use:

1. The red light is intended to treat periorbital wrinkles.
1. The blue light is intended to treat mild to moderate inflammatory acne.
1. The Red + IR is intended to treat periorbital wrinkles.

Product codes

OHS, OLP

Device Description

The TheraFace LED device is a lightweight device which uses specified wavelengths of LED light. For LED light irradiation function, the device produces light in the red light region of the spectrum (633±10nm), combination of IR and Red light (830nm±10nm&633 ± 10 nm), or in the blue light region of the spectrum(415±10nm).

The TheraFace LED device consists of a main control unit and its attachment applicators for the LED irradiation ring, which can be controlled by the device control button. The device is powered by one internal lithium rechargeable battery which can be charged by an external batterv charger.

Red light mode: In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit The output is adjustable to one wavelength with a narrow spectral bandwidth in red light. It provides narrow bands of red-light energy and is intended to treat periorbital 633±10nm. wrinkles.

Blue light mode: In blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is adjustable to one wavelength with a narrow spectral bandwidth in 415 ±10nm. It provides narrow bands of blue light energy to facial skin, and is intended to treat mild to moderate inflammatory acne.

Red+ IR mode: When the device is operated in the red combined with infrared light mode, it emits LED light in the RED (633 nm) and IR (830 nm) spectrum on facial skin. It is intended to treat periorbital wrinkles.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Face

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A series of studies were completed to demonstrate the substantial equivalence of TheraFace LED to the predicate device. All testing was conducted in accordance with and in conformance to applicable device regulations and guidance. Results of all testing demonstrate the device is non-toxic, is comparable to other currently marketed devices and is substantially equivalent to legally marketed predicates and included:

Biocompatibility

ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity. (Biocompatibility).
ISO 10993-10 :2010, biological evaluation of medical devices part 10: tests for irritation and skin sensitization. (Biocompatibility).

Electrical Safety and Electromagnetic Compatibility

IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 (or IEC 60601-1:2012 reprint) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC / EN 60601-1-2: 2014-02, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility.
IEC 60601-1-11 :2015. Medical electrical equipment part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home health care environment.
IEC 60601-2-57: 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
IEC 62471:2006, Photobiological safety of lamps and lamp systems.
AAMI TIR69:2017, ANSI C63.27-2017 Wireless Coexistence Test

Performance Bench Testing
The following performance bench testing was conducted: Usability Study Report, TheraFace LED Light Power Density Test Report

Clinical Performance Testing
There were no clinical studies performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K171821, K162489

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 21, 2021

Theragun, Inc. % Thomas Padula Vice President Regulatory Compliance Schiff & Company, Inc. 583 Mountain Avenue North Caldwell, New Jersey 07006

Re: K212155

Trade/Device Name: TheraFace LED Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS, OLP, IRO Dated: July 7, 2021 Received: July 12, 2021

Dear Thomas Padula:

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 (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 located 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.

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K212155

Device Name TheraFace LED

Indications for Use (Describe)

The device can work in multiple function modes as following with different indication for use:

1. The red light is intended to treat periorbital wrinkles.
1. The blue light is intended to treat mild to moderate inflammatory acne.
1. The Red + IR is intended to treat periorbital wrinkles.

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)

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510(k) Summary K212155 (as required by 807.92)

(1) SUBMITTER:

THERAGUN, Inc. 6100 Wilshire Blvd Suite 200 Los Angeles, CA 90048 Registration Number: 3012386142 FEI Number: 3012386142 Contact person: CJ Frederick, III - Director, Regulatory Compliance Telephone: 310-570-8341 Email: cj.frederick(@therabodycorp.com Date prepared: December 16, 2021

Application Correspondent:

Contact Person: Thomas Padula Company: Schiff & Company, Inc. Address: 583 Mountain Avenue, North Caldwell, NJ 07006 Tel: 201-317-8810 Email: thomaspadula@schiffandcompany.com

(2) DEVICE NAME:

Trade Name: TheraFace LED Common Name: Light Emitting Diode (LED) Device Classification Name: Light Based Over the Counter Wrinkle Reduction, over-the counter powered light-based laser for acne Device Classification: Class II Review Panel: General & Plastic Surgery Requlation Number: 21 CFR 878.4810, 890.5975 Product Code: OHS, OLP

(3) PREDICATE DEVICE(S): Substantial equivalence is based on following legally marketed devices.

| Sponsor | Heat In A Click | Zhongshan Bisen Plastic
Electronic Products Co., Ltd. |
|--------------------------|-----------------------------|----------------------------------------------------------|
| Device Name and
Model | 2 Face / Face Evolution | RED Light Device |
| 510(k) Number | K171821 (Primary Predicate) | K162489 |
| Product Code | OHS, OLP | OHS |
| Regulation Number | 878.4810 | 878.4810 |
| Regulation Class | II | II |

4

(4) DESCRIPTION OF THE DEVICE:

The TheraFace LED device is a lightweight device which uses specified wavelengths of LED light. For LED light irradiation function, the device produces light in the red light region of the spectrum (633±10nm), combination of IR and Red light (830nm±10nm&633 ± 10 nm), or in the blue light region of the spectrum(415±10nm).

The TheraFace LED device consists of a main control unit and its attachment applicators for the LED irradiation ring, which can be controlled by the device control button. The device is powered by one internal lithium rechargeable battery which can be charged by an external batterv charger.

Red light mode: In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit The output is adjustable to one wavelength with a narrow spectral bandwidth in red light. It provides narrow bands of red-light energy and is intended to treat periorbital 633±10nm. wrinkles.

Blue light mode: In blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is adjustable to one wavelength with a narrow spectral bandwidth in 415 ±10nm. It provides narrow bands of blue light energy to facial skin, and is intended to treat mild to moderate inflammatory acne.

Red+ IR mode: When the device is operated in the red combined with infrared light mode, it emits LED light in the RED (633 nm) and IR (830 nm) spectrum on facial skin. It is intended to treat periorbital wrinkles.

(5) INDICATIONS FOR USE:

The device can work in multiple function modes as following with different indication for use:

1. The red light is intended to treat periorbital wrinkles.
1. The blue light is intended to treat mild to moderate inflammatory acne.
1. The Red + IR is intended to treat periorbital wrinkles.
(6) COMPARISON WITH PREDICATE DEVICES: The following table is a comparison of TheraFace led and predicate devices.

TheraFace LED is substantially equivalent in terms of the technological characteristics, features, specifications, materials, mode of operation and indications for use, to 2 Face / Face Evolution - K171821 (Primary Predicate), RED Light Device K162489, cleared for marketing under 510(K).

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| Elements of
Comparison | Subject Device | Primary Predicate Device | Supplement
Predicate
Device 1 | Remark | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----|
| Basic Unit Characteristics | | | | | |
| Device Name and
Model | TheraFace LED | 2 Face / Face Evolution | RED Light Device BZ-0606 | -- | |
| 510 (K) Number | Applying | K171821 | K162489 | -- | |
| Product Code | OHS, OLP | OHS, OLP | OHS | See Note A
above | |
| Regulation
Number | 878.4810 | 878.4810 | 878.4810 | See Note A
above | |
| Intended Use | 1) The red light is intended to
treat periorbital wrinkles.

The blue light is intended to
treat mild to moderate
inflammatory acne.
The Red + IR is intended
to treat periorbital wrinkles. | 2 Face / Face
Evolution is a hand-held
device for over the
counter aesthetic purposes.
The Photon mode:
The red light is
intended for the
treatment of periorbital
wrinkles and the blue
light is intended for the
treatment of the mild to
moderate inflammatory
acne. | The RED Light Device is an
OTC device indicated to emit
energy in the red and IR
region of the spectrum for
use in dermatology for the
treatment of periorbital
wrinkles. | SE
Note 1
Only
compared
with its LED
photon
mode with
K171821. | |
| Apply parts | Face | Face | Face | SE | |
| Power Sources | Lithium battery :2x3.7V | DC 3.7V 2200mAh | Adaptor:100~240V
50/60Hz
Lithium battery: 2x3.7V | AC SE | |
| Method of Line
Current Isolation | Battery Supply | Battery Supply | Battery Supply | SE | |
| Indic
ator
Displ
| On/Off
Status | Yes | Yes | -- | SE |
| Elements of
Comparison | Subject Device | Primary Predicate Device | Supplement
Predicate
Device 1 | Remark | |
| ay
Low
Battery | Yes | Yes | -- | SE | |
| Voltage/C
urrent
Level | Yes | Yes | -- | SE | |
| Time Range | Red light: 5 - 7 minutes per
treatment zone

Blue: 5 - 7 minutes per treatment
zone

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Comparison in Detail(s):

Note 1:

For red light irradiation mode and blue light irradiation mode, the subject device can be substantially equivalent to predicate device K171821, which was defined as primary predicate device.

For Red light combined with Infrared light, it can be substantially equivalent to predicate device K162489.

Note 2:

Even though there is a console weight difference between the subject device and predicate devices; they all are portable medical devices and comply with IEC60601-1 testing. Therefore, such a minor difference would not affect safety and effectiveness.

Note 3 (LED Wavelengths; Power density):

For LED wavelength:

Although there is a Minor difference of the LED wavelengths between the subject and predicate devices due to deviation tolerance of LED wavelength, they all belong to the range of red, blue and infrared light wavelengths, and the device passed the testing according to IEC60601-2-57, so such minor difference on wavelength would not affect safety or effectiveness.

For LED Power density:

8

There is only minor difference of the power density between the subject and predicate devices; and the device passed the testing according to IEC60601-2-57, so such a minor deviation would not affect safety and effectiveness.

Note 4

Even though there is a difference for the material between the subject device and the predicate device, its material complies with ISO10993-5 and ISO10993-10.

(7) PERFORMANCE STANDARDS APPLIED:

A series of studies were completed to demonstrate the substantial equivalence of TheraFace LED to the predicate device. All testing was conducted in accordance with and in conformance to applicable device regulations and guidance. Results of all testing demonstrate the device is non-toxic, is comparable to other currently marketed devices and is substantially equivalent to legally marketed predicates and included:

Biocompatibility

ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity. (Biocompatibility).
ISO 10993-10 :2010, biological evaluation of medical devices part 10: tests for irritation and skin sensitization. (Biocompatibility).

Electrical Safety and Electromagnetic Compatibility

IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 (or IEC 60601-1:2012 reprint) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC / EN 60601-1-2: 2014-02, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility.
IEC 60601-1-11 :2015. Medical electrical equipment part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home health care environment.

9

IEC 60601-2-57: 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.

IEC 62471:2006, Photobiological safety of lamps and lamp systems.

AAMI TIR69:2017, ANSI C63.27-2017 Wireless Coexistence Test

(8) PERFORMANCE TESTING BENCH

The following performance bench testing was conducted: Usability Study Report, TheraFace LED Light Power Density Test Report

(9) PERFORMANCE TESTING CLINICAL

There were no clinical studies performed.

(10) CONCLUSION: TheraFace LED has the same indications for use and technology characteristics as the predicate devices. TheraFace LED is as safe, as effective, and performs as well as the predicate devices.