Who is the manufacturer of dermalux Flex MD?

Aesthetic Technology, Ltd. filed the 510(k) submission for dermalux Flex MD (K202028).

What is the FDA product code for dermalux Flex MD?

ILY. It is classified under 21 CFR 890.5500 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for dermalux Flex MD?

510(k) clearance (submission type: Traditional).

What are the predicate devices for dermalux Flex MD?

Biophotas Celluma 3 Phototherapy System (K152280, K171323); Rejuvalite MD (K133896); Opera Lebody (K201107).

Who can help prepare an FDA 510(k) submission like dermalux Flex MD?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

dermalux Flex MD

K202028 · Aesthetic Technology, Ltd. · ILY · Dec 16, 2020 · Physical Medicine

Device Facts

Record ID	K202028
Device Name	dermalux Flex MD
Applicant	Aesthetic Technology, Ltd.
Product Code	ILY · Physical Medicine
Decision Date	Dec 16, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5500
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 use in dermatology for the treatment of periorbital and full face wrinkles.

Device Story

Dermalux Flex MD is a Class II phototherapy system using narrow-band LED light (Blue 415nm, Red 633nm, Near Infrared 830nm). Device consists of a flexible LED array and a capacitive touch controller. For facial treatments, array is placed in a base; for body treatments, array is removed and placed over the target area. System delivers specific wavelengths to treat dermatological and musculoskeletal conditions. User selects treatment via controller, which manages duration via pre-set timer and software. Device provides topical heating, pain relief, acne reduction, and wrinkle treatment. Intended for OTC use. Benefits include non-invasive management of pain, acne, and skin aging.

Clinical Evidence

No clinical data. Bench testing only. Device verified against consensus standards including EN/IEC 60601-1, 60601-1-2, 60601-1-11, 62304, 62471, 60601-2-57, 62366-1, 60601-1-6, and ISO 10993-1.

Technological Characteristics

LED-based light source; wavelengths: 415nm, 633nm, 830nm. Flexible LED array form factor. Capacitive touch controller. Power: 100-240Vac, 50/60Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62471, IEC 60601-2-57, IEC 62366-1, ISO 10993-1. Software-controlled timer.

Indications for Use

Indicated for patients requiring topical heating for minor muscle/joint pain, arthritis, muscle spasm, stiffness, muscle relaxation, and increased local blood circulation; reduction of mild to moderate inflammatory acne vulgaris; and treatment of periorbital and full face wrinkles.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

Biophotas Celluma 3 Phototherapy System (K152280, K171323)
Rejuvalite MD (K133896)
Opera Lebody (K201107)

Related Devices

K212275 — Dermalux Flex MD · Aesthetic Technology, Ltd. · Nov 18, 2021
K200659 — Dermalux Tri-Wave MD · Aesthetic Technology, Ltd. · May 9, 2020
K120460 — SMARTLUX · Medmix Co., Ltd. · Oct 1, 2012
K233077 — FlashHeal 2 (FlashHeal 2.0) · Inwound Aps · Jan 18, 2024
K060792 — ILLUMIMED · Photoactif, LLC · Dec 1, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 16, 2020 Aesthetic Technology Ltd % Richard Hamer US Agent/Consultant Richard Hamer Associates LLC 705 Spring Lakes Blvd Bradenton, Florida 34210 Re: K202028 Trade/Device Name: Dermalux Flex MD Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: ILY, OLP, OHS Dated: November 19, 2020 Received: November 23, 2020 ### 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. {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 and Part 809); 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 (OS) 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 medical devices and radiation-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 Acting 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202028 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 use in dermatology for the treatment of periorbital and full face wrinkles. Type of Use (Select one or both, as applicable)X 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." {3}------------------------------------------------ ## 510(k) SUMMARY ## I. ADMINISTRATIVE #### Submitter: Aesthetic Technology Ltd. 211 Europa Blvd. Warrington, Cheshire WA5 7TN United Kingdom +44 (0)845 689 1789 Contact Person: Dale Needham Date of Preparation: December 11, 2020 ### II. DEVICE NAME Proprietary Name: Dermalux® Flex MD Common Name: Infrared Lamp; Powered Light Based Non-Laser Surgical Instrument Classification Name: Infrared Lamp; Laser surgical instrument for use in general and plastic surgery and in dermatology Regulation Number: 21 CFR §878.4810 and §890.5500 Regulatory Class: Class II Product Code: ILY, OLP, OHS ### III. PREDICATE DEVICES Biophotas Celluma 3 Phototherapy System: K152280 and K171323, Biophotas Inc .; Rejuvalite MD; K133896, Trophy Skin Inc. and Opera Lebody; K201107, GTG Wellness Co. Ltd. ### 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 {4}------------------------------------------------ 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 wavelength combinations. 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 The Dermalux Flex MD 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 ioint 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. The Dermalux Flex MD is 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 Devices (K152280 and K171323) | Secondary Predicate K133896 | Secondary Predicate K201107 | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Product name | Dermalux® Flex MD Phototherapy System | Biophotas Celluma3 | Rejuvalite MD | Opera Lebody | | Product code | ILY, OHS, OLP | ILY, OHS, OLP | OHS | OHS | | Regulation No. | 21 CFR 878.4810 and 21 CFR 890.5500 | 21 CFR 878.4810 and 21 CFR 890.5500 | 21 CFR 878.4810 | 21 CFR 878.4810 | | Class | Class II | Class II | Class II | Class II | | Intended use | Use of the red, blue and near-infrared regions of the spectrum to emit energy to treat dermatological and musculoskeletal conditions. | Use of the red, blue and near-infrared regions of the spectrum to emit energy to treat dermatological and musculoskeletal conditions | Use of the red and near- infrared regions of the spectrum to emit energy to treat full face wrinkles | Use of the red and near- infrared regions of the spectrum to emit energy to treat full face wrinkles | | 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 | The BioPhotas Celluma3 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; | Intended for use in the treatment of full face wrinkles | Intended for use in the treatment of full face wrinkles | ## VI. COMPARISON TO PREDICATE DEVICES {5}------------------------------------------------ | | 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. | promoting relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum is intended to reduce mild to moderate inflammatory acne vulgaris. The Celluma3 is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital (K152280) and full face (K171323) wrinkles | | | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------| | Parameter | Subject Device | Predicate Devices (K152280 and K171323 | Secondary Predicate K133896 | Secondary Predicate K201107 | | Power supply | 100-240Vac, 50/60Hz, 4.6 -1.85A, 460-430W. | 110 - 120V | 110-120V | Not stated | | Wavelength | Red light: 633nm±5nm Blue light: 415nm±5nm NIR light: 830nm±5nm | Red light: 640nm +/-25nm Blue light: 465nm NIR light: 880nm +/- 50nm | Red Light: 600, 622, 600nm NIR Light: 860nm | Red Light: 630 nm NIR Light: 830 nm | | Panels Type | 1 Panel | 1 Panel | 1 Panel | 1 Panel (Mask) | | Light frequency | N/A as DC Power | N/A as DC Power | N/A as DC Power | N/A as DC Power | | Output Power | Red - 633nm (11.5mW/cm²) Blue - 415nm (5.52mW/cm²) NIR - 830nm (5.5mW/cm²) | 6.5 mW/cm² | 62 mW/cm² (at 4 " distance) | 50 mW/cm² | | Standard dose in Joules | Red: 20J/cm² Blue: 10J/cm² NIR: 10J/cm² | 11.7 J/cm² | 11.2 J/cm² | 30J/cm² | | Treatment area | 792 cm² | 773 cm² | 90 cm² | Not stated | | Treatment time | Up to 30 minutes | Up to 30 minutes | 3 minutes | 10 minutes | | Operation interface | Device uses a pre-set timer and software to control treatment duration. | Device uses a timer and software to control treatment duration. | Device uses a timer to control treatment duration. | Device uses a timer to control treatment duration. | | Software | Yes | Yes | No | No | | Use | OTC | OTC | OTC | OTC | Substantial equivalence is readily evidenced by comparison of product attributes summarized in above. Apparent differences in output power and standard dose do not impact safety and 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: {6}------------------------------------------------ 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 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. {7}------------------------------------------------ ## VIII. CONCLUSION Based on design considerations and testing of product attributes, we conclude that the Dermalux® Flex MD performs at least as well as the above-mentioned predicate devices. The Dermalux® Flex MD is therefore considered to be as safe, as effective, and to perform as well as the legally marketed predicate devices.