# K002853: Sciton Image Hair Removal Laser

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Dec 4, 2000 after 82 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.
228 later devices descend from it; 1 cites it directly.
0 of 229 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
- K023881: Profile 1064 Laser System (2003), 227 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
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own

Source page: https://510kreport.com/device/K002853
Methodology: https://510kreport.com/methodology