# K020107: Smartepil

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: Feb 7, 2002 after 27 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.
10 later devices descend from it; 2 cite it directly.
0 of 11 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 its predicate without a number.
- (no number) Acclaim Laser: named in the summary without a submission number

## Most influential descendants
- K031828: Naturalase LP ND:Yag Laser (2003), 5 descendants of its own
- K041829: Focus Medical Naturalase LP and Naturalight Family of Products (2004), 4 descendants of its own
- K081219: Apollo Mini Ipl System (2008), 3 descendants of its own
- K043521: Biosyag 50 Med (2005), 3 descendants of its own
- K110304: Apex ER. Yag / Ipl System (2011), 2 descendants of its own

## Indications for use
The SMARTEPIL Laser is indicated for benign vascular lesions and hair removal.

Source page: https://510kreport.com/device/K020107
Methodology: https://510kreport.com/methodology