510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852761Substantially Equivalent

Cilas Model Ym101

Inframed, Inc., Brookline Village MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852761 is the FDA 510(k) clearance record for CILAS MODEL YM101, a class II device, cleared for Inframed, Inc. on under FDA product code LLO (Laser, Neodymium:Yag, Pulmonary Surgery). FDA records list 3 510(k) clearances for Inframed, Inc., from to . As of , FDA records show no recalls naming K852761.

Clearance record

Decision date
Received
(139 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
Inframed, Inc. P.O. Box 761, Brookline Village MA
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