510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881499Substantially Equivalent

Surgilase Yag 100 for Gynecology Use

Surgilase, Inc., Warwick RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881499 is the FDA 510(k) clearance record for SURGILASE YAG 100 FOR GYNECOLOGY USE, a class II device, cleared for Surgilase, Inc. on under FDA product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery). FDA records list 19 510(k) clearances for Surgilase, Inc., from to . As of , FDA records show no recalls naming K881499.

Clearance record

Decision date
Received
(38 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
Surgilase, Inc. I-95 Corporate Park, Warwick RI
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