# K021304: Prolite Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: Big Sky Laser Technologies, Inc.
- Decided: Jul 23, 2002 after 90 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
- K081095: Prolite Iii Tower and PR and HR Handpiece (2008), 0 descendants of its own

## Indications for use
The ProLitem Pulsed Light System, equipped with the HR handpiece and 600 nanometer filter, is intended for the removal of unwanted hair in all Fitzpatrick skin types. The ProLitem Pulsed Light System, equipped with the SR handpiece and 550 or 580 nanometer filters, is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow facial veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions The 550 nanometer filter may be more efficient for Types I and 11 skin. The 580 nanometer filter may be more efficient for Types I11 and IV skin. The Center for Medical Devices and Radiological Health has concluded that the ProLitem Pulsed Light System be labeled as a restricted device as follows: “CAUTION: Federal (US) law restricts the use of this device to licensed professionals.”

Source page: https://510kreport.com/device/K021304
Methodology: https://510kreport.com/methodology