# K073048: Peterio Universal Laser Scanning Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Scilex, Ltd.
- Decided: Feb 28, 2008 after 122 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
Longest line of descent: 1 generation back to K901008 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990014: Dioscan, Diomed, Inc. (1999) Summary page 1.
- K984339: Medart 455 Scanner System, Del Mar Technologies, Inc. (1999) Summary page 1.
- K901008: Hexascan Handpiece, Lihtan Technologies, Inc. (1990) Summary page 1.

## Indications for use
The Peterio Universal Laser Scanning Handpiece is intended to be used as an accessory to a compatible non-ablative 1064nm laser and for its legally marketed, dermatological indications including: Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin; Coagulation and hemostasis of sub-surface vascular lesions.

Source page: https://510kreport.com/device/K073048
Methodology: https://510kreport.com/methodology