510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923531Substantially Equivalent

Optoscalpel I Laser System

Optomed, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923531 is the FDA 510(k) clearance record for OPTOSCALPEL I LASER SYSTEM, a class II device, cleared for Optomed Corp. on under FDA product code HQB (Photocoagulator And Accessories). FDA records list 7 510(k) clearances for Optomed Corp., from to . As of , FDA records show no recalls naming K923531.

Clearance record

Decision date
Received
(484 days to decision)
Product code
HQB Photocoagulator And Accessories
Regulation
21 CFR 886.4690
Device class
Class II
Review panel
Ophthalmic
Applicant
Optomed Corp. 8920 Business Park Dr., Austin TX
510(k) summary
Summary
Third party review
No

Clearances, product code HQB

Trailing 12 months

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

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