510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881494Substantially Equivalent for Some Indications

Four Modifications to Ophthalas Argon/dye Laser

Biophysic Medical, Inc., Pleasant Hill CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K881494 is the FDA 510(k) clearance record for FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER, a class II device, cleared for Biophysic Medical, Inc. on under FDA product code HQF (Laser, Ophthalmic). FDA records list 11 510(k) clearances for Biophysic Medical, Inc., from to . As of , FDA records show no recalls naming K881494.

Clearance record

Decision date
Received
(144 days to decision)
Product code
HQF Laser, Ophthalmic
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Biophysic Medical, Inc. 2440 Estand Way, Pleasant Hill CA
Third party review
No

Clearances, product code HQF

Trailing 12 months
2 clearances under product code HQF in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260