510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K855095Substantially Equivalent

S.l.t. Contact Laser Nd:yag Use in Pulmonary Airwa

Surgical Laser Technologies, Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855095 is the FDA 510(k) clearance record for S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA, a class II device, cleared for Surgical Laser Technologies, Inc. on under FDA product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery). FDA records list 51 510(k) clearances for Surgical Laser Technologies, Inc., from to . As of , FDA records show no recalls naming K855095.

Clearance record

Decision date
Received
(57 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
Surgical Laser Technologies, Inc. 250 E 5th St. Suite 1500, Cincinnati OH
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