# K202442: Carewear Firefly Wrinkle Reduction

- Pathway: 510(k) (Traditional)
- Applicant: Carewear Corp.
- Decided: Nov 19, 2020 after 85 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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.

Source page: https://510kreport.com/device/K202442
Methodology: https://510kreport.com/methodology