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
K850728Substantially Equivalent

Model 4000 Nd:yag Laser for Gastrointestional Blee

Cooper Lasersonics, Inc., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850728 is the FDA 510(k) clearance record for MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE, a class II device, cleared for Cooper Lasersonics, Inc. on under FDA product code LNK (Laser For Gastro-Urology Use). FDA records list 54 510(k) clearances for Cooper Lasersonics, Inc., from to . As of , FDA records show no recalls naming K850728.

Clearance record

Decision date
Received
(45 days to decision)
Product code
LNK Laser For Gastro-Urology Use
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cooper Lasersonics, Inc. 3420 Central Expy. ., Santa Clara CA
Third party review
No

Clearances, product code LNK

Trailing 12 months

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

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