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LED Light Source

by Sunoptic Technologies, LLC

510(k) K093792

LED Light Source is a Class II device made by Sunoptic Technologies, LLC, cleared under FDA 510(k) K093792 on 18 Mar 2010, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093792 Date18 Mar 2010ClearedStatusActive

Official records

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  • Withdrawn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
FCW
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K093792

5 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K093792
UDI-DISize and differences
7153
PENTAX of America Inc.
715304961333231096
Prescription: yes
On the market
7153-02
PENTAX of America Inc.
7153-0204961333233977
Prescription: yes
On the market
7154
PENTAX of America Inc.
715404961333240494
Prescription: yes
On the market
Stryker 48252106
TEDAN SURGICAL INNOVATIONS, L.L.C.
4825210600843059116694
Prescription: no
On the market
TSI ML-0051
TEDAN SURGICAL INNOVATIONS, L.L.C.
ML-005100843059112351
Prescription: no
On the market

Similar devices

Other devices filed under FDA product code FCW (Light Source, Fiberoptic, Routine).

Other devices from Sunoptic Technologies

See all devices from Sunoptic Technologies →