# K112141: Smartepil,Depilase Yag Lase Plus

- Pathway: 510(k) (Traditional)
- Applicant: Castle Laser Systems, Limited
- Decided: Apr 13, 2012 after 262 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Smartepil: named in the summary without a submission number
- (no number) Depilase Yag Lase Plus: named in the summary without a submission number

## Indications for use
The CLS001 Laser System is intended to effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI, including sun tanned skin types. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing after a treatment regime The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI, including suntanned skin types.

Source page: https://510kreport.com/device/K112141
Methodology: https://510kreport.com/methodology