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Peterio Universal Laser Scanning Handpiece

by Scilex, Ltd.

510(k) K073048

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073048 Date28 Feb 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Peterio Universal Laser Scanning Handpiece is a handheld accessory designed for non-ablative 1064 nm laser systems. It attaches to the distal end of a compatible laser and employs rotating mirrors to distribute laser energy across a predefined surface area, enabling precise and rapid scanning.

This device is intended for use with legally marketed, compatible laser systems and is supplied as a reusable accessory. It is not classified as single-use and requires proper handling and maintenance as per manufacturer guidelines. The Peterio Universal Laser Scanning Handpiece holds an FDA 510(k) clearance under the product code GEX, with no third-party review involved.