(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.
§ 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.