# K082423: NO!NO! Skin

- Pathway: 510(k) (Traditional)
- Applicant: Radiancy (Israel), Ltd.
- Decided: Dec 3, 2008 after 103 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K102477: NO!NO! Skin (2010), 0 descendants of its own

## Indications for use
No! No! Skin is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K082423
Methodology: https://510kreport.com/methodology