510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864610Substantially Equivalent

Cilas Ym 101 Nd:yag Laser for Neurological Use

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

K864610 is the FDA 510(k) clearance record for CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE, a class III device, cleared for Inframed, Inc. on under FDA product code LLF (Laser, Neurosurgical, Argon). FDA records list 3 510(k) clearances for Inframed, Inc., from to . As of , FDA records show no recalls naming K864610.

Clearance record

Decision date
Received
(210 days to decision)
Product code
LLF Laser, Neurosurgical, Argon
Device class
Class III
Review panel
Unknown
Applicant
Inframed, Inc. 100 Crescent Rd., Needham MA
Third party review
No

Clearances, product code LLF

Trailing 12 months

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

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