(139 days)
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.
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.
The provided document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than providing extensive clinical study data to prove novel efficacy or meet specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria, specific device performance against those criteria, and detailed clinical study methodologies is not available in this document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of specific clinical acceptance criteria or human-centered performance metrics. Instead, it compares the technical characteristics of the Oxylight device (the "subject device") with predicate devices to argue for substantial equivalence in safety and efficacy.
The relevant "performance data" section focuses on safety testing against recognized electrical and electromagnetic compatibility standards.
| Standard | Test Title | Test Article | Acceptance Criteria (Implicit) | Reported Performance |
|---|---|---|---|---|
| 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 | Compliance with standard IEC 60601-1 | 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 | Compliance with standard EN 60601-1-2 et al. | Pass |
| ISO 14971:2012 | Medical devices – Application of risk management to medical devices | Not directly tested (risk management applied) | Application of risk management principles | Applied |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "Clinical testing was not performed with this device."
Therefore, there is no test set in the sense of a patient cohort, nor data provenance from such a set. The "test article" for safety testing was the device itself (OxyLight / Sapphire 3 OxyLight).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical testing was performed, no ground truth was established by experts for a test set in a clinical context.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as indicated by the statement "Clinical testing was not performed with this device."
The document does not mention any human reader performance or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Oxylight is a physical device (LED panel, microdermabrasion, oxygen spray) for dermatological use, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the purpose of substantial equivalence, the "ground truth" implicitly relies on the established safety and efficacy of the predicate devices with similar technical characteristics and indications for use. For the safety tests conducted, the ground truth was compliance with the specified international safety and EMC standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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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 (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
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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 indermatology |
| 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, SurgicalPowered, | 878.4810 | GEX | 2 |
| MicrodermabrasionHandpiece | Brush, DermabrasionPowered | 878.4820 | GFE | Class I, 510k exempt |
| Oxygen SprayHandpieces | 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 AMWolfsmantel 46 | LEDA — ApplicatorSCR 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 BlueLight PanelComponent | Subject Device | Primary Predicate Device | ReferencePredicate Device | SubstantialEquivalent |
| Device Name | OxyLight | BioPhotas LifeLight | Omnilux Blue | |
| Applicant | RAJA TradingCompany, Inc. | BioPhotas, Inc. | PhotoTherapeuticsLimited | |
| Listing | K200104 | K122237 | K030883 | |
| ClassificationNameClass/ProductCode/Regulation | Laser Instrument,Surgical PoweredClass II/GEX/878.4810 | Laser Instrument,Surgical PoweredClassII/GEX/878.4810 | Laser Instrument,Surgical PoweredClassII/GEX/878.4810 | Yes |
| Indications forUse | To treat dermatologicalconditions, specificallyto treat mild tomoderate acnevulgaris. | The blue lightspectrum is intendedto reduce mild tomoderate acnevulgaris. | Dermatologicalconditions andspecifically totreat moderateinflammatoryacne vulgaris. | Yes |
| Wavelength ofBlue Light | 465 nm +/- 5nm | 464 nm +/- 5nm | 415 +/-5 nm | Yes |
| Energy OutputinJoules/cm2 | 54 joules/cm2 | 19.6 joules/cm2 | 48 joules/cm² | Different fromthe PrimaryPredicate Devicebut similar intechnologicalcharacteristics tothe referencepredicate device. |
| Power OutputLevel mW/cm² | 45 milliwatts/cm² | Unknown | 40 milliwatts/cm² | Different fromthe PrimaryPredicate Devicebut similar intechnological |
| characteristics tothe referencepredicate device. | ||||
| Design andMode of Action | Panel with an array ofLED Lights | Panel with an arrayof LED Lights | Panel with anarray of LED Lights | Yes |
| PanelDimensions | 41.4cm x 23cm x19.2cm | Unknown | 31.8cm x 35.6cm x8.9cm | Yes |
| RecommendedTreatment Time | 20 minutes | 30 minutes | 20 minutes | Yes |
| Patient Contact | None | None | None | Yes |
| Laser Type | LED | LED | LED | Yes |
| OperationInterface | Display Screen | Unknown | Display Screen | Yes |
PARISON OF TECHNICAL CHARA
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| Red LED LightPanelComponent | Subject Device | Predicate Device | SubstantialEquivalent |
|---|---|---|---|
| Device NameApplicant | OxyLightRAJA TradingCompany, Inc. | Omnilux RevivePhoto TherapeuticsLimited | |
| Listing | K200104 | K030426 | |
| ClassificationNameClass/ProductCode/Regulation | Laser Instrument,Surgical PoweredClass II/GEX/878.4810 | Laser Instrument,Surgical PoweredClass II/GEX/878.4810 | Yes |
| Indications forUse | Indicated for use indermatology fortreatment ofsuperficial, benignvascular, andpigmented lesions. | Indicated for use indermatology fortreatment ofsuperficial, benignvascular, andpigmented lesions. | Yes |
| Wavelength ofRed Light | 625 nm +/- 5nm | 633 +/- 5 nm | Yes |
| Energy FluencyJoules/cm2 | 120 joules/cm2 | 126 joules/cm² | Yes |
| Power Output atSkin LevelmW/cm² | 100 milliwatts/cm² | 105 milliwatts/cm² | Yes |
| Design andMode of Action | Panel with an array ofLED Lights | Panel with an arrayof LED Lights | Yes |
| PanelDimensions | 41.4cm x 23cm x19.2cm | 31.8cm x 35.6cm x8.9cm | Yes |
| RecommendedTreatment Time | 20 minutes | 20 minutes | Yes |
| Patient Contact | None | None | Yes |
| Laser Type | LED | LED | Yes |
| OperationInterface | Display Screen | Display Screen | Yes |
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| Yellow LED PDTLight PanelComponent | Subject Device | Reference PredicateDevice | SubstantialEquivalent |
|---|---|---|---|
| Device Name | OxyLight | LEDA - Applicator SCR585 | |
| Applicant | RAJA TradingCompany, Inc. | Quantel DermaGMBHAM Wolfsmantel 46 | |
| Listing | K200104 | K090762 | |
| ClassificationNameClass/ProductCode/Regulation | Laser Instrument,Surgical PoweredClass II/GEX/878.4810 | Laser Instrument,Surgical PoweredClassII/GEX/878.4810 | Yes |
| Intended Use | Generally indicated fortreatment ofperiorbital wrinklesand rhytides. | Generally indicatedfor treatment ofperiorbital wrinklesand rhytides. | Yes |
| Wavelength ofYellow Light | 590 nm +/- 5nm | 585 nm +/- 5nm | Yes |
| Energy FluencyJoules/cm2 | 42 joules/cm2 | 0.1 - up to 100joules/cm2 | Yes |
| Power Output atSkin LevelmW/cm² | 35 milliwatts/cm² | 4mW/cm² –120mW/cm² | Yes |
| PanelDimensions | 41.4cm x 23cm x19.2cm | 45cm x 41cm x 24 cm | Yes |
| Design andMode of Action | Panel with an array ofLED Lights | Panel with an arrayof LED Lights | Yes |
| RecommendedTreatment Time | 20 minutes | Unknown | Yes |
| Patient ContactMaterials | None | None | Yes |
| Laser Type | LED | LED | Yes |
| OperationInterface | Display Screen | Display Screen | Yes |
PERFORMANCE DATA
Safety Testing
| Standard | Test Title | Test Article | Test Results |
|---|---|---|---|
| IEC 60601-1:2005 +CORR. 1:2006 +CORR. 2:2007 +AM1:2012 | Medical electrical equipment Part 1: Generalrequirements for basic safety and essentialperformance | OxyLight | Pass |
| EN 60601-1-2:2015EN 61000-3-2:2014EN 61000-2-3:2013 | Medical electrical equipment -Part 1-2:General requirements for basic safety andessential performance-Collateral standard: Electromagneticcompatibility- Requirements and tests | Sapphire 3OxyLight* | 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.
§ 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.