(147 days)
Not Found
No
The 510(k) summary describes a light therapy device with pre-set wavelength combinations selected via a touch controller. There is no mention of AI, ML, or any adaptive or learning capabilities. The device description focuses on the hardware (LEDs, flexible array, controller) and the physical mechanism of action (light wavelengths).
Yes.
The device is intended to provide pain relief, reduce inflammation, and treat wrinkles, all of which are considered therapeutic applications.
No
The device's intended use and indications for use describe therapeutic functions (elevating tissue temperature, pain relief, increasing blood circulation, reducing inflammatory acne, treating wrinkles), not diagnostic functions.
No
The device description clearly outlines physical hardware components such as an LED Array, a Base, and a capacitive touch Controller, which are essential for its function of emitting light for treatment. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Dermalux® Flex MD is a light therapy device that applies light directly to the body's surface. It does not involve the collection or analysis of any biological specimens.
- Intended Use: The intended uses described are for topical heating, pain relief, muscle relaxation, increased blood circulation, and the treatment of acne and wrinkles. These are all direct treatments applied to the body, not diagnostic tests performed on samples.
Therefore, the Dermalux® Flex MD falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 the use in dermatology for the treatment of periorbital and full face wrinkles.
Product codes
ILY, OLP, OHS
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital and full face, face and the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K152280, K171323, K133896, K201107
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
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.(b)
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.
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.