# K013365: Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of Tattoos

- Pathway: 510(k) (Traditional)
- Applicant: Medical Bio Care Sweden AB
- Decided: Jan 8, 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.
1,127 later devices descend from it; 4 cite it directly.
0 of 1,128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K060772: Manuel Saftey Syringe Parts 1 & 2, Medsafe Asa (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K023954: Altus Medical Coolglide Laser Systems and Accessories (2003), 1,117 descendants of its own
- K033946: Lovely System (2004), 737 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own
- K032460: Profile BBL System (2003), 569 descendants of its own

## Indications for use
The ProLite Pulsed Light System is intended for the treatment of benign pigmented lesions and the removal of tattoos.

Source page: https://510kreport.com/device/K013365
Methodology: https://510kreport.com/methodology