# K081095: Prolite Iii Tower and PR and HR Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Quantel S.A.
- Decided: Dec 12, 2008 after 239 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: 1 generation back to K021304 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021304: Prolite Pulsed Light System, Big Sky Laser Technologies, Inc. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K021303: ProLite. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
The ProLite III TM Pulsed Light System with the HR handpiece (containing a 630-1100 nm, 630-990 nm, or 750-1100 nm filter) is intended for the removal of unwanted hair in all Fitzpatrick skin types. The ProLite III TM Pulsed Light System with the PR handpiece (containing a 530-1100 nm, 550-1100 nm, or 580-1100 nm filter) is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions.

Source page: https://510kreport.com/device/K081095
Methodology: https://510kreport.com/methodology