# K010005: Cynosure Photogenica DL

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Apr 2, 2001 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.
855 later devices descend from it; 2 cite it directly.
0 of 856 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
- K024064: Polaris DS (2003), 681 descendants of its own
- K030186: Polris LV (2003), 680 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K051214: Aluma Skin Renewal System (2005), 476 descendants of its own
- K052324: Polaris LV, Lva Applicator (2005), 456 descendants of its own

Source page: https://510kreport.com/device/K010005
Methodology: https://510kreport.com/methodology