(85 days)
The Carewear® Firefly® Wrinkle Reduction device is an over the counter, battery operated, wearable device which emits energy in the red region of the spectrum, specifically indicated to treat fine lines and wrinkles.
The Carewear® Firefly® Wrinkle Reduction device is an over the counter, battery operated, wearable device which emits energy in the red region of the spectrum.
I am sorry, but the provided text from the FDA 510(k) clearance letter for the Carewear Firefly Wrinkle Reduction device does not contain any information about acceptance criteria or the study that proves the device meets those criteria.
This document is a clearance letter, confirming that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It outlines regulatory requirements, product codes, and indications for use.
To answer your request, I would need a different type of document, such as:
- A Clinical Study Report: This would detail the methodology, acceptance criteria, results, and statistical analysis of a study conducted to demonstrate the device's effectiveness.
- A 510(k) Summary or Decision Summary (if available and more detailed than this letter): While the clearance letter itself is often brief, sometimes the FDA publishes a more extensive summary of the data reviewed.
- The original 510(k) submission documentation: This would contain the full technical and clinical data submitted by the manufacturer.
Without this information, I cannot provide the details you've requested regarding acceptance criteria and study particulars. The current text only states the device's Indications for Use: "The Carewear® Firefly® Wrinkle Reduction device is an over the counter, battery operated, wearable device which emits energy in the red region of the spectrum, specifically indicated to treat fine lines and wrinkles." This is what the device claims to do, but not how that claim was proven or the metrics used for proof.
§ 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.