510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870505Substantially Equivalent

Optilase Yag Model 1000 Surg Laser Sys/pulmon Appl

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

K870505 is the FDA 510(k) clearance record for OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL, a class II device, cleared for Trimedyne, Inc. on under FDA product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery). FDA records list 58 510(k) clearances for Trimedyne, Inc., from to . As of , FDA records show no recalls naming K870505.

Clearance record

Decision date
Received
(184 days to decision)
Product code
LLO Laser, Neodymium:Yag, Pulmonary Surgery
Regulation
21 CFR 874.4500
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Trimedyne, Inc. 1815 E. Carnegie Ave., Santa Ana CA
Third party review
No

Clearances, product code LLO

Trailing 12 months

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

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