# K010927: Modification to Prolite Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Bio Care Sweden AB
- Decided: Jun 19, 2001 after 83 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.
1,118 later devices descend from it; 1 cites it directly.
0 of 1,119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K010927
Methodology: https://510kreport.com/methodology