Oxylight

K200104 · Raja Trading Company, Inc. · GEX · Jun 4, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K200104
• Device Name: Oxylight
• Applicant: Raja Trading Company, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

OxyLight is a multi-modality skin therapy system for use by physicians and healthcare professionals in clinical settings. It integrates three modalities: LED light therapy (Blue 465nm, Red 625nm, Yellow 590nm), microdermabrasion, and oxygen spray. The system utilizes a universal control unit with a display screen to power various attachments, including an LED light panel and separate handpieces for microdermabrasion and oxygen delivery. LED therapy treats acne, vascular/pigmented lesions, and wrinkles via light-based phototherapy. Microdermabrasion provides mechanical skin exfoliation, while oxygen spray refreshes the skin. The device is operated by clinicians to provide non-invasive dermatological treatments. Clinical decision-making is guided by the practitioner's assessment of the patient's skin condition, with the device providing targeted therapeutic light or mechanical/topical skin care. Benefits include non-invasive treatment of specific dermatological conditions and skin rejuvenation.

Clinical Evidence

No clinical data was performed. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1) and electromagnetic compatibility (EN 60601-1-2) testing.

Technological Characteristics

System utilizes LED arrays for phototherapy (465nm, 625nm, 590nm), microdermabrasion handpieces, and oxygen spray. Energy source is a universal control unit. Dimensions: 41.4cm x 23cm x 19.2cm. Operation via display screen interface. No patient contact during LED therapy. Sterilization/biocompatibility not specified. Software/algorithm details not provided.

Indications for Use

Indicated for dermatological use by physicians/healthcare professionals to treat moderate inflammatory acne vulgaris (Blue LED), superficial benign vascular and pigmented lesions (Red LED), and periorbital wrinkles/rhytides (Yellow LED). Also indicated for skin exfoliation (microdermabrasion) and refreshing skin (oxygen spray).

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

• BioPhotas LifeLight (K122237)
• Omnilux Revive (K030426)
• LEDA — Applicator SCR 585 (K090762)

Reference Devices

• Omnilux Blue (K030883)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

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# 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<br>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<br>Powered, | 878.4810 | GEX | 2 |
| Microdermabrasion<br>Handpiece | Brush, Dermabrasion<br>Powered | 878.4820 | GFE | Class I, 510k exempt |
| Oxygen Spray<br>Handpieces | Not Applicable | Not Applicable | Not Applicable | General Wellness |

#### Legally Marketed Equivalent Devices

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

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

#### PARISON OF TECHNICAL CHARA

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

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

# PERFORMANCE DATA

# Safety Testing

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

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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.