Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device using LED technology, microdermabrasion, and oxygen spray, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML mentions.

Therapeutic

Yes
The device is intended to treat dermatological conditions, including inflammatory acne vulgaris, superficial lesions, and wrinkles, using LED technology, which are considered therapeutic applications.

Diagnostic

No
The provided text describes the Oxylight system as a skin therapy system intended for various treatments (e.g., dermatological conditions, wrinkles, exfoliation, refreshing skin) using LED technology, microdermabrasion, and oxygen spray. It focuses on therapeutic applications and does not mention any function for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "skin therapy system that uses three major modalities delivered by different attachments powered from a single energy source and operated from a universal control unit," including LED Light Panel Therapy, Microdermabrasion, and Oxygen Spray. These are hardware components, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the device is for "dermatological use by physicians and healthcare professionals" for treating skin conditions (acne, lesions, wrinkles) and for skin exfoliation and refreshing. This is a direct treatment applied to the patient's body.
Device Description: The description details modalities like LED light therapy, microdermabrasion, and oxygen spray, all of which are applied externally to the skin.
Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.

The device is a therapeutic and aesthetic device used for direct application to the patient's skin.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Oxylight 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

GEX, GFE

Device Description

The Oxylight system is a skin therapy system that uses three major modalities delivered by different attachments powered from a single energy source and operated from a universal control unit. The treatments include, LED Light Panel Therapy (Class 2), Microdermabrasion (Class 1, 510k exempt) and Oxygen Spray. The Oxygen Spray is delivered through the same panel used for LED light therapy and separate handpieces.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Safety Testing:

IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 - Medical electrical equipment Part 1: General requirements for basic safety and essential performance. Test Article: OxyLight. Results: Pass.
EN 60601-1-2:2015 EN 61000-3-2:2014 EN 61000-2-3:2013 - Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests. Test Article: Sapphire 3 OxyLight*. Results: Pass.

ISO 14971:2012 – Medical devices – Application of risk management to medical devices.
Clinical testing was not performed with this device.

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

Not Found

Predicate Device(s)

K122237, K030426, K090762

Reference Device(s)

K030883

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

June, 4, 2020

Image /page/0/Picture/1 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.

RAJA Trading Company, Inc. % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114

Re: K200104

Trade/Device Name: Oxylight 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 14, 2020 Received: March 10, 2020

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.

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

1

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 (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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin Kejing Chen 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

Enclosure

2

Indications for Use

510(k) Number (if known) K200104

Device Name OxyLight

Indications for Use (Describe)

The Oxylight 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

K200104 510(k)Summary

SPONSOR

Company Name:	RAJA Trading Company Inc.
Company Address:	801 South Olive Avenue
	Suite 124
	West Palm Beach, Florida 33401
Telephone:	561-868-4600
Fax:	561-258-0207
Contact Person:	Robert J. Adipietro
Title:	VP

Summary Preparation Date: June 4, 2020

DEVICE NAME

Trade Name:	OxyLight
Common/Usual Name:	LED Phototherapy, Microdermabrasion, Oxygen Spray
Classification Name:	Laser surgical instrument for use in general and plastic surgery and in
dermatology
Regulation Number:	21 CFR 878.4810; 878.4820
Product Code:	GEX, GFE
Device Class:	Class II

Attachment	Regulation Name	Regulation No.	Product code	Class
Panel	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

Legally Marketed Equivalent Devices

| LED BLUE Light

Primary | BioPhotas, Inc. | BioPhotas LifeLight | K122237 |
|-------------------------------|-----------------------------------------|------------------------------|---------|
| LED BLUE Light
Reference | Photo Therapeutics Ltd | Omnilux Blue | K030883 |
| LED RED Light
Primary | Photo Therapeutics Ltd | Omnilux Revive | K030426 |
| LED YELLOW -
Primary | Quantel Derma GMBH AM
Wolfsmantel 46 | LEDA — Applicator
SCR 585 | K090762 |

4

The Oxylight system is a skin therapy system that uses three major modalities delivered by different attachments powered from a single energy source and operated from a universal control unit. The treatments include, LED Light Panel Therapy (Class 2), Microdermabrasion (Class 1, 510k exempt) and Oxygen Spray. The Oxygen Spray is delivered through the same panel used for LED light therapy and separate handpieces.

DEVICE INDICATIONS FOR USE

The Oxylight 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.

COMPARISON OF TECHNICAL CHARACTERISTICS
LED PDT Blue
Light Panel
Component	Subject Device	Primary Predicate Device	Reference
Predicate Device	Substantial
Equivalent
Device Name	OxyLight	BioPhotas LifeLight	Omnilux Blue
Applicant	RAJA Trading
Company, Inc.	BioPhotas, Inc.	Photo
Therapeutics
Limited
Listing	K200104	K122237	K030883
Classification
Name
Class/Product
Code/Regulation	Laser Instrument,
Surgical Powered
Class II/GEX/878.4810	Laser Instrument,
Surgical Powered
Class
II/GEX/878.4810	Laser Instrument,
Surgical Powered
Class
II/GEX/878.4810	Yes
Indications for
Use	To treat dermatological
conditions, specifically
to treat mild to
moderate acne
vulgaris.	The blue light
spectrum is intended
to reduce mild to
moderate acne
vulgaris.	Dermatological
conditions and
specifically to
treat moderate
inflammatory
acne vulgaris.	Yes
Wavelength of
Blue Light	465 nm +/- 5nm	464 nm +/- 5nm	415 +/-5 nm	Yes
Energy Output
in
Joules/cm2	54 joules/cm2	19.6 joules/cm2	48 joules/cm²	Different from
the Primary
Predicate Device
but similar in
technological
characteristics to
the reference
predicate device.
Power Output
Level mW/cm²	45 milliwatts/cm²	Unknown	40 milliwatts/cm²	Different from
the Primary
Predicate Device
but similar in
technological
				characteristics to
the reference
predicate device.
Design and
Mode of Action	Panel with an array of
LED Lights	Panel with an array
of LED Lights	Panel with an
array of LED Lights	Yes
Panel
Dimensions	41.4cm x 23cm x
19.2cm	Unknown	31.8cm x 35.6cm x
8.9cm	Yes
Recommended
Treatment Time	20 minutes	30 minutes	20 minutes	Yes
Patient Contact	None	None	None	Yes
Laser Type	LED	LED	LED	Yes
Operation
Interface	Display Screen	Unknown	Display Screen	Yes

PARISON OF TECHNICAL CHARA

5

| Red LED Light
Panel
Component | Subject Device | Predicate Device | Substantial
Equivalent |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------|
| Device Name
Applicant | OxyLight
RAJA Trading
Company, Inc. | Omnilux Revive
Photo Therapeutics
Limited | |
| Listing | K200104 | K030426 | |
| Classification
Name
Class/Product
Code/Regulation | Laser Instrument,
Surgical Powered
Class II/GEX/878.4810 | Laser Instrument,
Surgical Powered
Class II/GEX/878.4810 | Yes |
| Indications for
Use | Indicated for use in
dermatology for
treatment of
superficial, benign
vascular, and
pigmented lesions. | Indicated for use in
dermatology for
treatment of
superficial, benign
vascular, and
pigmented lesions. | Yes |
| Wavelength of
Red Light | 625 nm +/- 5nm | 633 +/- 5 nm | Yes |
| Energy Fluency
Joules/cm2 | 120 joules/cm2 | 126 joules/cm² | Yes |
| Power Output at
Skin Level
mW/cm² | 100 milliwatts/cm² | 105 milliwatts/cm² | Yes |
| Design and
Mode of Action | Panel with an array of
LED Lights | Panel with an array
of LED Lights | Yes |
| Panel
Dimensions | 41.4cm x 23cm x
19.2cm | 31.8cm x 35.6cm x
8.9cm | Yes |
| Recommended
Treatment Time | 20 minutes | 20 minutes | Yes |
| Patient Contact | None | None | Yes |
| Laser Type | LED | LED | Yes |
| Operation
Interface | Display Screen | Display Screen | Yes |

6

| Yellow LED PDT
Light Panel
Component | Subject Device | Reference Predicate
Device | Substantial
Equivalent |
|------------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------|
| Device Name | OxyLight | LEDA - Applicator SCR
585 | |
| Applicant | RAJA Trading
Company, Inc. | Quantel Derma
GMBH
AM Wolfsmantel 46 | |
| Listing | K200104 | K090762 | |
| Classification
Name
Class/Product
Code/Regulation | Laser Instrument,
Surgical Powered
Class II/GEX/878.4810 | Laser Instrument,
Surgical Powered
Class
II/GEX/878.4810 | Yes |
| Intended Use | Generally indicated for
treatment of
periorbital wrinkles
and rhytides. | Generally indicated
for treatment of
periorbital wrinkles
and rhytides. | Yes |
| Wavelength of
Yellow Light | 590 nm +/- 5nm | 585 nm +/- 5nm | Yes |
| Energy Fluency
Joules/cm2 | 42 joules/cm2 | 0.1 - up to 100
joules/cm2 | Yes |
| Power Output at
Skin Level
mW/cm² | 35 milliwatts/cm² | 4mW/cm² –
120mW/cm² | Yes |
| Panel
Dimensions | 41.4cm x 23cm x
19.2cm | 45cm x 41cm x 24 cm | Yes |
| Design and
Mode of Action | Panel with an array of
LED Lights | Panel with an array
of LED Lights | Yes |
| Recommended
Treatment Time | 20 minutes | Unknown | Yes |
| Patient Contact
Materials | None | None | Yes |
| Laser Type | LED | LED | Yes |
| Operation
Interface | Display Screen | Display Screen | Yes |

PERFORMANCE DATA

Safety Testing

Standard	Test Title	Test Article
IEC 60601-1:2005 +
CORR. 1:2006 +
CORR. 2:2007 +
AM1:2012	Medical electrical equipment Part 1: General
requirements for basic safety and essential
performance	OxyLight	Pass
EN 60601-1-2:2015
EN 61000-3-2:2014
EN 61000-2-3:2013	Medical electrical equipment -Part 1-2:
General requirements for basic safety and
essential performance-
Collateral standard: Electromagnetic
compatibility- Requirements and tests	Sapphire 3
OxyLight*	Pass

7

ISO 14971:2012 – Medical devices – Application of risk management to medical devices. Clinical testing was not performed with this device.

*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.

CONCLUSION

The OxyLight is similar to the predicate devices in indications for use, principle of operation and technological characteristics. Differences do not introduce new issues of safety and effectiveness and are thus substantially equivalent to the predicate. Non-clinical tests (IEC 60601-1:2005 + CORR. 2:2007 + AM1:2012, and EN 60601-1-2:2015) demonstrate that the proposed device is as safe and perform as well as the predicate devices. The proposed device is Substantially Equivalent (SE) to the predicate devices.