510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902263Substantially Equivalent

Optilase Model 1000 Nd:yag Laser Add'l Indication

Trimedyne, Inc., Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902263 is the FDA 510(k) clearance record for OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION, a class I device, cleared for Trimedyne, Inc. on under FDA product code GGX (Pipette, Sahli). FDA records list 58 510(k) clearances for Trimedyne, Inc., from to . As of , FDA records show no recalls naming K902263.

Clearance record

Decision date
Received
(63 days to decision)
Product code
GGX Pipette, Sahli
Regulation
21 CFR 864.6160
Device class
Class I
Review panel
Hematology
Applicant
Trimedyne, Inc. 1311 Valencia Ave., Tustin CA
Third party review
No

Clearances, product code GGX

Trailing 12 months

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

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