Dermalux Flex MD

K212275 · Aesthetic Technology, Ltd. · OHS · Nov 18, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K212275
• Device Name: Dermalux Flex MD
• Applicant: Aesthetic Technology, Ltd.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Nov 18, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. Intended to emit energy in the red and infrared spectrum for the treatment of periorbital and full face wrinkles.

Device Story

Dermalux Flex MD is a light-based phototherapy system using blue (415nm), red (633nm), and near-infrared (830nm) LEDs. Device consists of a flexible LED array and a capacitive touch controller. Used in clinical or home settings; operated by patient or clinician. User selects treatment via controller; device emits specific wavelengths to target skin/tissue. For facial treatments, array is placed in a base; for body, array is applied directly to the area. Device uses pre-set timers to control treatment duration. Output provides topical heating, pain relief, acne reduction, and wrinkle treatment. Benefits include non-invasive management of dermatological and musculoskeletal conditions.

Clinical Evidence

No clinical or animal studies were performed. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), photobiological safety (IEC 62471), and software lifecycle processes (IEC 62304).

Technological Characteristics

LED-based phototherapy system; wavelengths: 415nm (blue), 633nm (red), 830nm (near-infrared). Flexible LED array form factor. Power: 100-240Vac, 50/60Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62304, IEC 62471, IEC 60601-2-57, IEC 62366-1, ISO 10993-1. Software-controlled timer.

Indications for Use

Indicated for patients seeking temporary relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, and promotion of muscle relaxation/local blood circulation. Also indicated for reduction of mild to moderate inflammatory acne vulgaris and treatment of periorbital and full-face wrinkles.

Regulatory Classification

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.

Predicate Devices

• Dermalux Flex MD (K202028)
• Flexible LED Light Therapy Model HK209 (K200983)

Reference Devices

• Omnilux CLEAR (K210948)
• Biophotas Celluma3 (K152280)

Submission Summary (Full Text)

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November 18, 2021

Aesthetic Technology Ltd. % Richard Hamer US Agent/Consultant Richard Hamer Associates, LLC 705 Spring Lakes Blvd Bradenton, Florida 34210

Re: K212275

Trade/Device Name: Dermalux Flex MD 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, ILY Dated: October 19, 2021 Received: October 25, 2021

Dear Richard Hamer:

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.

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K212275

Device Name

Dermalux Flex MD

Indications for Use (Describe)

Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris.

Intended to emit energy in the red and infrared spectrum for the treatment of periorbital and full face wrinkles.

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# K212275

## 510(k) SUMMARY

### I. ADMINISTRATIVE

### Submitter:

Aesthetic Technology Ltd. 211 Europa Blvd. Warrington, Cheshire WA5 7TN United Kingdom [phone]

Contact Person: Dale Needham

Date of Preparation: November 18, 2021

### II. DEVICE NAME

Proprietary Name: Dermalux® Flex MD

Common Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology

Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over-The Counter Wrinkle Reduction (OHS) and Lamp Infrared, Therapeutic Heating (ILY),

Regulation Number: 21 CFR §878.4810

Regulatory Class: Class II

Product Code: OLP, OHS, ILY

### III. PREDICATE DEVICES

Dermalux® Flex MD; K202028, Aesthetic Technology Ltd.

Flexible LED Light Therapy Model HK209; K200983, Guangzhou GLOOMED Biological Technology Co. Ltd.

In addition, Omnilux CLEAR; K210948, GlobalMed Technologies and Biophotas Celluma3; K152280, Biophotas, Inc. are cited as reference devices for the purpose of establishing labeling equivalence.

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# IV. DEVICE DECRIPTION

The Dermalux® Flex MD is a Class II medical device for use on a treatment bed. The device emits specific wavelengths of low level, narrow band light for the treatment of certain dermatological and musculoskeletal indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm.

The Dermalux® Flex MD enables treatment of the face and the body via a flexible LED Array. The system is operated by a capacitive touch Controller, which allows one of 3 treatments to be selected through selecting various wavelengths. The light is generated by Light Emitting Diodes (LED's) that are contained within the flexible LED Array. The LED Array can be placed into the Base, holding in the appropriate position to administer a facial treatment. For use on the body, the LED Array is removed from the Base unit and placed over the appropriate body part.

## V. INDICATIONS FOR USE

Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris.

Intended to emit energy in the red and infrared spectrum for use in dermatology for the treatment of periorbital and full face wrinkles.

| Parameter | Subject Device | Predicate Device (K202028) | Secondary Predicate (K200983) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Dermalux® Flex MD<br>Phototherapy System | Dermalux® Flex MD<br>Phototherapy System | Flexible LED Light Therapy<br>Model HK209 |
| Product code | OHS, OLP. ILY | ILY, OHS, OLP | OHS, OLP, ILY |
| Regulation No. | 21 CFR 878.4810<br>21 CFR 890.5500 | 21 CFR 878.4810<br>21 CFR 890.5500 | 21 CFR 878.4810<br>21 CFR 890.5500 |
| Class | Class II | Class II | Class II |
| Intended use | Use of the red, blue and near-<br>infrared regions of the spectrum<br>to emit energy to treat dermato-<br>logical and musculoskeletal<br>conditions. | Use of the red, blue and near-<br>infrared regions of the spectrum<br>to emit energy to treat dermato-<br>logical and musculoskeletal<br>conditions | Use of the red, blue and near-<br>infrared regions of the spectrum<br>to emit energy to treat dermato-<br>logical and musculoskeletal con-<br>ditions |
| Indications for use | Intended to deliver heat in the IR<br>spectrum to provide topical<br>heating for the purpose of ele-<br>vating tissue temperature; for the<br>temporary relief of minor muscle<br>and joint pain, arthritis and<br>muscle spasm; relieving stiff- | Intended to deliver heat in the IR<br>spectrum to provide topical<br>heating for the purpose of ele-<br>vating tissue temperature; for the<br>temporary relief of minor muscle<br>and joint pain, arthritis and<br>muscle spasm; relieving stiff- | The device emitting energy in the<br>blue spectrum is intended to re-<br>duce mild to moderate inflamma-<br>tory acne vulgaris.<br>The device emitting energy in the<br>red and infrared spectrum is in-<br>tended for the treatment of full- |

# VI. COMPARISON TO PREDICATE DEVICES

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| | ness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. Intended to emit energy in the red and infrared spectrum for the use in dermatology for the treatment of periorbital and full face wrinkles. | ness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris. Intended to emit energy in the red and infrared spectrum for the use in dermatology for the treatment of periorbital and full face wrinkles. | face wrinkles. The device is Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power supply | 100-240Vac, 50/60Hz, 4.6 - 1.85A, 460-430W. | 100-240Vac, 50/60Hz, 4.6 - 1.85A, 460-430W. | 100-240 Vac<br>2.0 A, 50/60Hz |
| Wavelength | Red light: 633nm±5nm<br>Blue light: 415nm±5nm<br>NIR light: 830nm±5nm | Red light: 633nm±5nm<br>Blue light: 415nm±5nm<br>NIR light: 830nm±5nm | Red light: 640nm<br>Blue light: 465nm<br>NIR Light: 880nm |
| Panels Type | 1 Panel | 1 Panel | 1 Panel |
| Light frequency | N/A as DC Power | N/A as DC Power | N/A as DC Power |
| Output Power | Red - 633nm (11.5mW/cm²)<br>Blue - 415nm (5.52mW/cm²)<br>NIR - 830nm (5.5mW/cm²) | Red - 633nm (11.5mW/cm²)<br>Blue - 415nm (5.52mW/cm²)<br>NIR - 830nm (5.5mW/cm² | 6.5 mW/cm² |
| Standard dose in Joules | Red: 20J/cm²<br>Blue: 10J/cm²<br>NIR: 10J/cm² | Red: 20J/cm²<br>Blue: 10J/cm²<br>NIR: 10J/cm² | 11.7 J/cm² |
| Treatment area | Face and Body<br>792 cm² | Face and Body<br>792 cm² | Face and Body<br>890 cm² |
| Treatment time | Up to 30 minutes | Up to 30 minutes | 30 minutes |
| Treatment protocol<br>(Treatment time) | Acne and Wrinkles: 3-4x weekly; 4 wks. Pain relief: 3x weekly | Not stated | 3x weekly; 4wks |
| Operation interface | Device uses a pre-set timer and software to control treatment duration. | Device uses a pre-set timer and software to control treatment duration. | Not stated |
| Software | Yes | Yes | Not stated |

Substantial equivalence is readily evidenced by comparison of product attributes summarized in the table above. Apparent differences in output power and standard dose do not impact safety or effectiveness because the amount of energy delivered to the skin is similar due to differences in treatment duration and distance from the LED source.

# VII. PERFORMANCE TESTING

Bench: Performance testing of the Dermalux® Flex MD was conducted to verify that the device met all design specifications. The test results demonstrate that the Dermalux® Flex MD complies with all requirements, including international and FDA-recognized consensus standards:

EN/IEC 60601-1 (FDA #19-4) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance: 2005

EN/IEC 60601-1-2 (FDA #19-8) Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests: 2018

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EN/IEC 60601-1-11 (FDA #19-14) 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 healthcare environment: 2015

EN/IEC 62304 (FDA #13-79) Medical device software - Software life cycle processes: 2006

EN/IEC 62471 (FDA #12-249) Photobiological safety of lamps and lamp systems: 2008

IEC 60601-2-57 (FDA #12-242) Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use: 2011

IEC 62366-1 (FDA #5-113) Medical devices - Part 1: Application of usability engineering to medical devices: 2015

EN/IEC 60601-1-6 (FDA #5-89) Medical electrical equipment -Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability: 2013

Photometric Testing of LED Light Panel

ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.

Animal: No studies were performed.

Clinical: No studies were performed.

### VIII. CONCLUSION

The Dermalux Flex MD is technologically identical to the predicate device cleared under K202028, intended for over-the-counter use, and similar to secondary predicate device K200983. Labeling is equivalent to reference devices K210948 and K152280. Based on design considerations and testing of product attributes, we conclude that the Dermalux® Flex MD performs at least as well as the predicate devices. The Dermalux® Flex MD is therefore considered to be substantially equivalent to the above-mentioned predicate devices.