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OptiScan TH OAM001858

by Quanta System SpA

OptiScan TH OAM001858 is a Class II device made by Quanta System SpA, cleared under FDA 510(k) K171711 on 7 Jul 2017 and listed in FDA GUDID since 8 Jun 2018 (UDI-DI 08033945938840), 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) K171711

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 Number08033945938840 UDI-DI Date8 Jun 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK171711 Date7 Jul 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171711 decided 7 Jul 2017 Active
  • FDA GUDID UDI-DI 08033945938840 listed 8 Jun 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171711
  2. Listed FDA GUDID 08033945938840

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
OptiScan TH
Generic name
Skin laser scanner
Model / reference
OAM001858
Primary DI / UDI-DI
08033945938840
510(k) Number
FDA product code
GEX
GMDN term
Skin laser scanner
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Skin laser scanner

Cleared under the same submission (K171711)

Similar devices

Also classified as Skin laser scanner.

Other devices from Quanta System SpA

See all devices from Quanta System SpA →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)