510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K833499Substantially Equivalent

Fiberlas 100 Medical System

Fiberlase U.S.A., 7600 Ridge Blvd Brooklun NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833499 is the FDA 510(k) clearance record for FIBERLAS 100 MEDICAL SYSTEM, a class II device, cleared for Fiberlase U.S.A. on under FDA product code LNK (Laser For Gastro-Urology Use). FDA records list one 510(k) clearance for Fiberlase U.S.A. As of , FDA records show no recalls naming K833499.

Clearance record

Decision date
Received
(180 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
Fiberlase U.S.A.
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