# K022807: Meladine Natural Melanin Enhancer, Product Number CT81602AA

- Pathway: 510(k) (Traditional)
- Applicant: Creative Technologies, Inc.
- Decided: Jan 29, 2003 after 159 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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
MeladineTM Natural Melanin Enhancer is indicated as a topical pretreatment prior to undergoing laser hair removal for patients suffering from unwanted, non-pigmented hair growth (white, grey, light blonde) who are unlikely to experience hair reduction with laser treatment alone.

Source page: https://510kreport.com/device/K022807
Methodology: https://510kreport.com/methodology