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Litho PVMS00037

by Quanta System SpA

Litho PVMS00037 is a Class II device made by Quanta System SpA, cleared under FDA 510(k) K141101 on 8 Aug 2014 and listed in FDA GUDID since 18 Aug 2016 (UDI-DI 08033945934644), 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) K141101

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 Number08033945934644 UDI-DI Date18 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK141101 Date8 Aug 2014IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141101 decided 8 Aug 2014 Active
  • FDA GUDID UDI-DI 08033945934644 listed 18 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141101
  2. Listed FDA GUDID 08033945934644

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Litho
Generic name
General/multiple surgical solid-state laser system
Model / reference
PVMS00037
Primary DI / UDI-DI
08033945934644
510(k) Number
FDA product code
GEX
GMDN term
General/multiple surgical solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: General/multiple surgical solid-state laser system

Similar devices in this category

Other devices filed under General/multiple surgical solid-state laser system.

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)