Skip to content

Spirit 916

by Active Optical Systems Ltd

Spirit 916 is a multi-modality skin surface treatment system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Active Optical Systems Ltd, cleared under FDA 510(k) K153718 on 12 Feb 2016 and listed in FDA GUDID since 2 Aug 2016 (UDI-DI 07290016727029), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K153718

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016727029 UDI-DI Date2 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153718 Date12 Feb 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153718 decided 12 Feb 2016 Active
  • FDA GUDID UDI-DI 07290016727029 listed 2 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153718
  2. Listed FDA GUDID 07290016727029

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Spirit
Generic name
Multi-modality skin surface treatment system
Model / reference
916
Primary DI / UDI-DI
07290016727029
510(k) Number
FDA product code
GEX
GMDN term
Multi-modality skin surface treatment system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multi-modality skin surface treatment system

Similar devices in this category

Other devices filed under Multi-modality skin surface treatment system.

Other devices from Active Optical Systems Ltd

  • Crystal 512

    Class II

  • Top Epil Classic 1

    Class I

  • Sheerwave 360

    Class II

  • Extra

    Class IIa

See all devices from Active Optical Systems Ltd →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)