OxyLight 2.0

K202175 · Raja Trading Company, Inc. · GEX · Dec 2, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202175
• Device Name: OxyLight 2.0
• Applicant: Raja Trading Company, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oxylight 2.0 is intended for dermatological use by physicians and healthcare professionals for the following: LED Technology is intended for: -Blue LED 465nm - to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. -Red LED 625nm- for treatment of superficial, benign vascular and pigmented lesions. - Yellow LED 590nm - treatment of periorbital wrinkles and rhytides. Microdermabrasion is intended for exfoliation of the skin. Oxygen spray is intended to refresh the skin.

Device Story

OxyLight 2.0 is a multi-modal skin therapy system; includes LED light panel, microdermabrasion handpiece, oxygen spray, and two new handheld LED 'MyoLight' applicators (face and body). Device inputs: user-selected treatment parameters via display screen. Principle of operation: LED light emission at specific wavelengths (465nm, 625nm, 590nm) for phototherapy; mechanical exfoliation via microdermabrasion; oxygen delivery for skin refreshing. Used in clinical settings by physicians and healthcare professionals. Output: light energy delivered to skin surface; mechanical skin exfoliation; oxygen spray. Clinical benefit: treatment of acne, vascular/pigmented lesions, and wrinkles; skin rejuvenation. System is an evolution of the predicate OxyLight (K200104) with added handheld LED functionality.

Clinical Evidence

No clinical data included. Substantial equivalence is supported by bench testing, software verification/validation, and compliance with international safety standards (IEC 60601 series) and biocompatibility requirements (ISO 10993).

Technological Characteristics

System includes LED panel (840 LEDs) and handheld LED applicators (8 LEDs for face, 18 for body). Wavelengths: 465nm (Blue), 625nm (Red), 590nm (Yellow). Energy/power outputs identical to predicate. Connectivity: display screen interface. Safety standards: IEC 60601-1, IEC 60601-1-2. Biocompatibility: ISO 10993.

Indications for Use

Indicated for patients requiring dermatological treatment for moderate inflammatory acne vulgaris, superficial benign vascular and pigmented lesions, and periorbital wrinkles and rhytides. Also indicated for skin exfoliation and refreshing.

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

• OxyLight (K200104)

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 2, 2021

Raja Trading Company, Inc. % Yolanda Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K202175

Trade/Device Name: OxyLight 2.0 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: GEX, GFE Dated: January 6, 2021 Received: January 7, 2021

Dear Yolanda Smith:

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 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 ([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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K202175

Device Name OxyLight 2.0

Indications for Use (Describe)

The Oxylight 2.0 is intended for dermatological use by physicians and healthcare professionals for the following: LED Technology is intended for:

-Blue LED 465nm - to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

-Red LED 625nm- for treatment of superficial, benign vascular and pigmented lesions.

- Yellow LED 590nm - treatment of periorbital wrinkles and rhytides.

Microdermabrasion is intended for exfoliation of the skin.

Oxygen spray is intended to refresh the skin.

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

This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92.

510(k) Number: K202175

- Date of Preparation 1. 12/02/2021
- 2. Applicant

| Name: | RAJA Trading Company Inc. |
|-----------------|------------------------------------------------|
| Address: | 2801 Juniper Street, Suite 2, Fairfax, VA 2203 |
| Contact Person: | Robert J. Adipietro |
| Title: | Vice President |
| Telephone: | 561-868-4600 |
| Fax: | 561-258-0207 |
| Email: | [e-mail] |

- 3. Identification of the Proposed Device Trade Name: OxyLight 2.0 Common Name: LED Phototherapy and Microdermabrasion Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Classification: Class II Product Code: GEX, GFE Regulation Number: 21 CFR 878.4810 Review Panel: General& Plastic Surgery

| Attachment | Regulation Name | Regulation No. | Product<br>code | Class |
|--------------------------------|----------------------------------------|----------------|-------------------|-------------------------|
| LED Panel | Laser Instrument, Surgical<br>Powered, | 878.4810 | GEX | 2 |
| LED Handpieces | Laser Instrument, Surgical<br>Powered, | 878.4810 | GEX | 2 |
| Microdermabrasion<br>Handpiece | Brush, Dermabrasion<br>Powered | 878.4820 | GFE | Class I, 510k<br>exempt |
| Oxygen Spray<br>Handpieces | Not Applicable | Not Applicable | Not<br>Applicable | General<br>Wellness |

- 4. Identification of Predicate Device

| 510(k) Number: | K200104 |
|----------------|---------------------------|
| Product Name: | OxyLight |
| Manufacturer: | RAJA Trading Company Inc. |

- 5. Device Description
The subject device Oxylight 2.0 is a skin therapy system that was modified from the predicate device OxyLight cleared previously under K200104 for the LED Light Panel Therapy (Class 2), Microdermabrasion (Class 1, 510k exempt) and Oxygen Spray (General Wellness). The OxyLight 2.0 system includes two new LED handpieces called MyoLight. The MyoLight handpieces connect to the main unit. The small handpiece (diameter: 3.9 cm, Length: 14 cm) is generally used on the face and the large handpiece (diameter: 6.2 cm, Length: 15 cm) is generally used on the body.

- 6. Indications for Use
The Oxylight 2.0 is intended for dermatological use by physicians and healthcare professionals for the following: LED Technology is intended for:

-Blue LED - 465nm - to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

-Red LED 625nm- for treatment of superficial, benign vascular and pigmented lesions.

{4}------------------------------------------------

- Yellow LED 590nm - treatment of periorbital wrinkles and rhytides.

Microdermabrasion is intended for exfoliation of the skin.
Oxygen spray is intended to refresh the skin.

- Substantially Equivalent (SE) Comparison 7.

| Specifications | Subject Device | Predicate Device | Comment |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Device Name | OxyLight 2.0 | OxyLight | N/A |
| 510(k) Number | K202175 | K200104 | N/A |
| Applicant | RAJA Trading Company,<br>Inc. | RAJA Trading Company,<br>Inc. | N/A |
| Intended use/ Product<br>Code | Powered laser surgical<br>instrument,<br>Power dermabrasion<br>Class II/GEX/878.4810<br>Class I/GFE/878.4820 | Powered laser surgical<br>instrument,<br>Power dermabrasion<br>Class II/GEX/878.4810<br>Class I/GFE/878.4820 | |
| Indications LED | -Blue LED Light - to treat<br>dermatological conditions<br>and specifically indicated<br>to treat mild to moderate<br>inflammatory acne<br>vulgaris.<br>-Red LED Light - for<br>treatment of superficial,<br>benign vascular and<br>pigmented lesions.<br>- Yellow LED Light -<br>treatment of periorbital<br>wrinkles and rhytides. | -Blue LED Light - to treat<br>dermatological conditions<br>and specifically indicated<br>to treat mild to moderate<br>inflammatory acne<br>vulgaris.<br>-Red LED Light - for<br>treatment of superficial,<br>benign vascular and<br>pigmented lesions.<br>- Yellow LED Light -<br>treatment of periorbital<br>wrinkles and rhytides. | Identical |
| Design and Mode of<br>Action | Panel with an array of<br>LED Lights. The LEDs<br>emit blue (465 nm), red<br>(625 nm) or yellow (590<br>nm) light. In addition, the<br>OxyLight 2.0 includes 2<br>hand-held handpieces that<br>house LED lights. The<br>hand-held handpieces<br>deliver the light to the<br>skin as they are moved<br>over the skin surface. | Panel with an array of LED<br>Lights. The LEDs emit<br>blue (465 nm), red (625<br>nm) or yellow (590 nm)<br>light. | Similar |
| No. of LEDs | Panel - 840<br>Face Handpiece - 8<br>Body Handpiece - 18 | Panel - 840 | Similar power<br>density and<br>energy flux |
| Treatment Time | 20 minutes | 20 minutes | Identical |
| Light Source | LED | LED | Identical |
| Operation Interface | Display Screen | Display Screen | Identical |
| Wavelength (Blue) | 465 nm +/- 5nm | 465 nm +/- 5nm | Identical |
| Energy Output (Blue) | 54 J/cm² | 54 J/cm² | Identical |
| Power Output (Blue) | 45 mW/cm² | 45 mW/cm² | Identical |
| Wavelength (Red) | 625 nm +/- 5nm | 625 nm +/- 5nm | Identical |
| Energy Output (Red) | 120 J/cm² | 120 J/cm² | Identical |
| Power Output (Red) | 100 mW/cm² | 100 mW/cm² | Identical |
| Wavelength (Yellow) | 590 nm +/- 5nm | 590 nm +/- 5nm | Identical |
| Energy Output (Yellow) | 42 J/cm² | 42 J/cm² | Identical |
| Power Output (Yellow) | 35 mW/cm² | 35 mW/cm² | Identical |

{5}------------------------------------------------

- 8. Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:

- > IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance*;
- > IEC 60601-1-2:2014/EN 60601-1-2:2015, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests**.
- > Biocompatibility Tests per ISO 10993 and FDA Guidance
- ハ Software Validation & Verification Test
- > Bench Testing to verify the performance

*The OxyLight 2.0 was tested with the LED Handpieces under the name OxyLight was cleared by the FDA K200104 with the LED Panel, Microdermabrasion and Oxygen Spray Modalities. The OxyLight 2.0 is the OxyLight with the addition of the LED handpieces.

** Sapphire 3 OxyLight is the same test article. Sapphire 3 is a trademark brand name that RAJA Trading Company, Inc. uses for its class of skin care devices. In addition, the OxyLight 2.0 was tested with the LED Handpieces under the name OxyLight. The OxyLight was cleared by the FDA K200104 with the LED Panel, Microdermabrasion and Oxygen Spray Modalities. The OxyLight 2.0 is the OxyLight with the addition of the LED handpiece.

#### 9. Clinical Testing

No clinical study is included in this submission.

- 10. Conclusion
Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.