(485 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called OxyLight 2.0. It is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device (OxyLight, K200104) and thus does not contain the typical structure of a study proving a device meets specific clinical acceptance criteria for an AI/algorithm-based device.
The "acceptance criteria" and "device performance" in this context refer to the technical specifications and safety standards that the OxyLight 2.0 must meet to be considered substantially equivalent to its predicate. There is no AI or algorithm involved, and therefore, no performance metrics like accuracy, sensitivity, or specificity relative to a diagnostic task are presented.
Instead, the "study" proving the device meets acceptance criteria primarily involves non-clinical bench testing, electrical safety, electromagnetic compatibility, and biocompatibility.
Here's an analysis based on the provided document, addressing your points where applicable, and noting where the information is not relevant to this type of device submission:
1. A table of Acceptance Criteria and the Reported Device Performance
For this device (OxyLight 2.0), the "acceptance criteria" are not clinical performance metrics for an AI, but rather technical specifications and safety standards aligned with the predicate device. The "reported device performance" is the confirmation that the new device meets these technical specifications and passes the required non-clinical tests.
| Criteria Type (Not "Acceptance Criteria" in AI Sense) | Specific Criterion (Based on Predicate) | Reported Device Performance (OxyLight 2.0) | Comment (from document) |
|---|---|---|---|
| Device Name | OxyLight | OxyLight 2.0 | N/A |
| 510(k) Number | K200104 | K202175 | N/A |
| Applicant | RAJA Trading Company, Inc. | RAJA Trading Company, Inc. | N/A |
| Intended use/Product Code | Powered laser surgical instrument,Power dermabrasionClass II/GEX/878.4810Class I/GFE/878.4820 | Powered laser surgical instrument,Power dermabrasionClass II/GEX/878.4810Class I/GFE/878.4820 | Identical |
| Indications for Use (LED) | (Specific wavelengths & conditions) | (Specific wavelengths & conditions) | Identical (for listed LED indications) |
| Design and Mode of Action | Panel with LED array | Panel with LED array + 2 handheld handpieces | Similar (addition of handpieces) |
| Number of LEDs (Panel) | 840 | 840 | Similar power density and energy flux |
| Number of LEDs (Handpieces) | N/A (Predicate had no handpieces) | Face Handpiece - 8, Body Handpiece - 18 | Implicitly, these must meet safety standards and produce specified light output. |
| 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 |
| Non-Clinical Testing | Compliance with standards (e.g., electrical safety, EMC, biocompatibility) | Compliance was verified via testing. | IEC 60601-1, IEC 60601-1-2, ISO 10993, Software V&V, Bench Testing. |
Note: This table reflects the comparison presented in the 510(k) summary, which is a key part of demonstrating substantial equivalence for physical devices.
Regarding AI/Algorithm-Specific Questions (Not applicable to this 510(k) submission):
This 510(k) submission is for a physical medical device (LED phototherapy and microdermabrasion system), not an AI/algorithm-based diagnostic or assistive software. Therefore, the following points are not applicable to this document:
- Sample sizes used for the test set and data provenance: No test set of patient data (e.g., images for classification) was used for performance evaluation of an algorithm. The testing was physical device validation.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth established by experts for an algorithm's performance, as there is no algorithm.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. There is no human-in-the-loop AI assistance being evaluated.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in the AI sense is not relevant here.
- The sample size for the training set: Not applicable, as there is no AI algorithm being developed or trained.
- How the ground truth for the training set was established: Not applicable, as there is no AI algorithm being developed or trained.
Summary of the Study Proving Device Meets Criteria (Based on the document):
The "study" conducted for the OxyLight 2.0 to prove it meets acceptance criteria (i.e., is substantially equivalent and safe/effective for its intended use) is documented under "8. Non-Clinical Testing".
- Type of Study: Non-clinical validation and verification.
- Tests Conducted:
- IEC 60601-1:2005/A1:2012: General Requirements for Basic Safety and Essential Performance (electrical safety).
- IEC 60601-1-2:2014/EN 60601-1-2:2015: Electromagnetic Compatibility (EMC).
- Biocompatibility Tests per ISO 10993 and FDA Guidance: To ensure materials in contact with skin are safe.
- Software Validation & Verification Test: For the device's operational software.
- Bench Testing: To verify the performance of the device's components and outputs (e.g., light wavelengths, energy/power outputs, and the function of the new handpieces).
- Assertions from the document: The applicant states these tests were "conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device."
- Data Provenance (Implicit): The tests were performed in a controlled laboratory setting, adhering to international standards. The data is prospective as it was generated specifically for this submission. The origin is likely the manufacturer or accredited testing labs.
- Clinical Testing: The document explicitly states, "No clinical study is included in this submission." This indicates that substantial equivalence was demonstrated without new clinical trials, relying on the established safety and efficacy of the predicate device and the non-clinical testing of the modifications.
In conclusion, for this specific 510(k) submission, the "acceptance criteria" are the established technical and safety specifications for similar devices, primarily the predicate. The "study" involves comprehensive non-clinical engineering and safety testing to demonstrate that the new device adheres to these specifications and introduces no new safety or efficacy concerns that would preclude a substantial equivalence determination.
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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.
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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
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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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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
-
- 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 |
-
- 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. | Productcode | Class |
|---|---|---|---|---|
| LED Panel | Laser Instrument, SurgicalPowered, | 878.4810 | GEX | 2 |
| LED Handpieces | Laser Instrument, SurgicalPowered, | 878.4810 | GEX | 2 |
| MicrodermabrasionHandpiece | Brush, DermabrasionPowered | 878.4820 | GFE | Class I, 510kexempt |
| Oxygen SprayHandpieces | Not Applicable | Not Applicable | NotApplicable | GeneralWellness |
-
- Identification of Predicate Device
| 510(k) Number: | K200104 |
|---|---|
| Product Name: | OxyLight |
| Manufacturer: | RAJA Trading Company Inc. |
-
- 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.
- Device Description
-
- 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:
- Indications for Use
-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.
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- 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/ ProductCode | Powered laser surgicalinstrument,Power dermabrasionClass II/GEX/878.4810Class I/GFE/878.4820 | Powered laser surgicalinstrument,Power dermabrasionClass II/GEX/878.4810Class I/GFE/878.4820 | |
| Indications LED | -Blue LED Light - to treatdermatological conditionsand specifically indicatedto treat mild to moderateinflammatory acnevulgaris.-Red LED Light - fortreatment of superficial,benign vascular andpigmented lesions.- Yellow LED Light -treatment of periorbitalwrinkles and rhytides. | -Blue LED Light - to treatdermatological conditionsand specifically indicatedto treat mild to moderateinflammatory acnevulgaris.-Red LED Light - fortreatment of superficial,benign vascular andpigmented lesions.- Yellow LED Light -treatment of periorbitalwrinkles and rhytides. | Identical |
| Design and Mode ofAction | Panel with an array ofLED Lights. The LEDsemit blue (465 nm), red(625 nm) or yellow (590nm) light. In addition, theOxyLight 2.0 includes 2hand-held handpieces thathouse LED lights. Thehand-held handpiecesdeliver the light to theskin as they are movedover the skin surface. | Panel with an array of LEDLights. The LEDs emitblue (465 nm), red (625nm) or yellow (590 nm)light. | Similar |
| No. of LEDs | Panel - 840Face Handpiece - 8Body Handpiece - 18 | Panel - 840 | Similar powerdensity andenergy 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 |
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-
- 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:
- Non-Clinical Testing
-
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.
-
- Conclusion
Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.
- Conclusion
§ 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.