# K012552: Sciton Image Hair Removal Laser

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Nov 5, 2001 after 89 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.
520 later devices descend from it; 1 cites it directly.
0 of 521 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) Altus Medical, Nd:YAG Aesthetic Laser: named in the summary without a submission number
- (no number) Laserscope, Long Pulse Nd:YAG: named in the summary without a submission number

## Most influential descendants
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own

## Indications for use
The Sciton, Inc. Image Hair Removal Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition it is intended to effect stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles (where permanent hair reduction is defined as a long term stable reduction in the number of hairs growing after a treatment regimen)

Source page: https://510kreport.com/device/K012552
Methodology: https://510kreport.com/methodology