# K080638: CLARO

- Pathway: 510(k) (Traditional)
- Applicant: Clrs Technology Corporation
- Decided: Sep 17, 2008 after 195 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
Longest line of descent: 7 generations back to K910422 (1992). 62 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060411: Radiancy Cleartouch Lite Acne Clearance System, Radiancy (Israel), Ltd. (2006) Summary page 1.
- K043377: ZENO, Tyrell, Inc. (2005) Summary page 1.
- K060653: Thermaclear, Dermacare, Inc. (2006) Summary page 1.
- K040081: Palomar Luxv Handpiece, Palomar Medical Technologies, Inc. (2004)
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 1.
- K051113: Quanta System Etrna Giovinezza, Quanta System Spa (2006)

## Most influential descendants
- K090744: CLARO (2010), 1 descendant of its own
- K150282: Shaser Skin Beauty Intense Pulsed Light System Family for Acne (2015), 0 descendants of its own

## Indications for use
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K080638
Methodology: https://510kreport.com/methodology