510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854793Substantially Equivalent for Some Indications

Monopolar Injection Needle Electrode

Oculinum, Inc., Mill Valley CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K854793 is the FDA 510(k) clearance record for MONOPOLAR INJECTION NEEDLE ELECTRODE, a class II device, cleared for Oculinum, Inc. on under FDA product code HLW (Preamplifier, Battery-Powered, Ophthalmic). FDA records list 3 510(k) clearances for Oculinum, Inc., from to . As of , FDA records show no recalls naming K854793.

Clearance record

Decision date
Received
(75 days to decision)
Product code
HLW Preamplifier, Battery-Powered, Ophthalmic
Regulation
21 CFR 886.1640
Device class
Class II
Review panel
Ophthalmic
Applicant
Oculinum, Inc. P. O. Box 175, Mill Valley CA
Third party review
No

Clearances, product code HLW

Trailing 12 months

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

FDA records show no clearances under product code HLW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HLW, 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