Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device utilizing LED technology, microdermabrasion, and oxygen spray for skin therapy. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

Yes
The device is intended to treat specific dermatological conditions like acne, vascular and pigmented lesions, and wrinkles, which falls under the definition of a therapeutic device.

Diagnostic

No

The device is described as a "skin therapy system" and its "Intended Use / Indications for Use" section outlines various treatments for dermatological conditions (acne, lesions, wrinkles), skin exfoliation, and skin refreshment. It does not mention any function for identifying, analyzing, or diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Oxylight 2.0 is a "skin therapy system" that includes a "main unit" and "two new LED handpieces called MyoLight" that "connect to the main unit." This indicates the device is a physical hardware system, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Oxylight 2.0 device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Oxylight 2.0 Function: The Oxylight 2.0 is a skin therapy system that uses LED light, microdermabrasion, and oxygen spray applied directly to the skin for therapeutic and cosmetic purposes. It does not involve testing samples taken from the body.
Intended Use: The intended use clearly describes treatments applied to the skin for dermatological conditions, not diagnostic testing of biological samples.
Device Description: The description details a system with handpieces that interact with the skin surface.
Lack of IVD Indicators: There is no mention of sample collection, analysis of biological materials, or diagnostic claims in the provided text.

Therefore, the Oxylight 2.0 falls under the category of therapeutic or aesthetic medical devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

GEX, GFE

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin, periorbital

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physicians and healthcare professionals

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)

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
Software Validation & Verification Test
Bench Testing to verify the performance

No clinical study is included in this submission.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K200104

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 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 (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 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)

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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
1. 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:	rja@rajamedical.com

1. 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
code | Class |
|--------------------------------|----------------------------------------|----------------|-------------------|-------------------------|
| LED Panel | Laser Instrument, Surgical
Powered, | 878.4810 | GEX | 2 |
| LED Handpieces | Laser Instrument, Surgical
Powered, | 878.4810 | GEX | 2 |
| Microdermabrasion
Handpiece | Brush, Dermabrasion
Powered | 878.4820 | GFE | Class I, 510k
exempt |
| Oxygen Spray
Handpieces | Not Applicable | Not Applicable | Not
Applicable | General
Wellness |

1. Identification of Predicate Device

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

1. 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.
1. 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,
Inc.	RAJA Trading Company,
Inc.	N/A
Intended use/ Product
Code	Powered laser surgical
instrument,
Power dermabrasion
Class II/GEX/878.4810
Class I/GFE/878.4820	Powered laser surgical
instrument,
Power dermabrasion
Class II/GEX/878.4810
Class I/GFE/878.4820
Indications LED	-Blue LED Light - to treat
dermatological conditions
and specifically indicated
to treat mild to moderate
inflammatory acne
vulgaris.
-Red LED Light - for
treatment of superficial,
benign vascular and
pigmented lesions.

Yellow LED Light -
treatment of periorbital
wrinkles and rhytides. | -Blue LED Light - to treat
dermatological conditions
and specifically indicated
to treat mild to moderate
inflammatory acne
vulgaris.
-Red LED Light - for
treatment of superficial,
benign vascular and
pigmented lesions.
Yellow LED Light -
treatment of periorbital
wrinkles and rhytides. | Identical |
| Design and Mode of
Action | Panel with an array of
LED Lights. The LEDs
emit blue (465 nm), red
(625 nm) or yellow (590
nm) light. In addition, the
OxyLight 2.0 includes 2
hand-held handpieces that
house LED lights. The
hand-held handpieces
deliver the light to the
skin as they are moved
over the skin surface. | Panel with an array of LED
Lights. The LEDs emit
blue (465 nm), red (625
nm) or yellow (590 nm)
light. | Similar |
| No. of LEDs | Panel - 840
Face Handpiece - 8
Body Handpiece - 18 | Panel - 840 | Similar power
density and
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

1. 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.

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