510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844895Substantially Equivalent

Oms Silicone Oil Injector

Optical Micro Systems, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844895 is the FDA 510(k) clearance record for OMS SILICONE OIL INJECTOR, a class III device, cleared for Optical Micro Systems, Inc. on under FDA product code LWL (Fluid, Intraocular). FDA records list 21 510(k) clearances for Optical Micro Systems, Inc., from to . As of , FDA records show no recalls naming K844895.

Clearance record

Decision date
Received
(189 days to decision)
Product code
LWL Fluid, Intraocular
Regulation
21 CFR 886.4275
Device class
Class III
Review panel
Ophthalmic
Applicant
Optical Micro Systems, Inc. 8 Electronics Ave., Danvers MA
Third party review
No

Clearances, product code LWL

Trailing 12 months

FDA records hold no clearances under product code LWL in the trailing twelve months.

FDA records show no clearances under product code LWL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260