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Stellar Exoscope 31103FA

by Guangdong Optomedic Technologies, Inc.

Stellar Exoscope 31103FA is a Class II device made by Guangdong Optomedic Technologies, Inc., cleared under FDA 510(k) K241530 on 7 Aug 2024 and listed in FDA GUDID since 15 Aug 2024 (UDI-DI 06973031299382), active as of 22 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 22 Oct 2026

Documents

510(k) K241530

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06973031299382 UDI-DI Date15 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241530 Date7 Aug 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241530 decided 7 Aug 2024 Active
  • FDA GUDID UDI-DI 06973031299382 listed 15 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241530
  2. Listed FDA GUDID 06973031299382

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Stellar Exoscope
Generic name
Surgical microscope video camera, sterilizable
Model / reference
31103FA
Primary DI / UDI-DI
06973031299382
510(k) Number
FDA product code
GCJ
GMDN term
Surgical microscope video camera, sterilizable
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).

Other devices from Guangdong Optomedic Technologies, Inc.

See all devices from Guangdong Optomedic Technologies, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)