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Cilas YM 101 Nd:YAG Laser for Neurological Use

by Inframed, Inc.

510(k) K864610

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864610 Date18 Jun 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLF
Device Class
Class III
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cilas YM 101 is a Neurosurgical Laser, Argon, Nd:YAG, classified as a Class III device under FDA regulations. This device employs a neodymium-doped yttrium aluminium garnet (Nd:YAG) laser, specifically designed for precision applications in neurological surgery, where controlled tissue ablation or coagulation is required.

The Cilas YM 101 is supplied as a reusable medical instrument and is intended for use in sterile surgical environments. It operates under FDA clearance (K864610) and adheres to traditional 510(k) review standards, with no indication of MRI compatibility or specific size variations noted in the regulatory submission. Storage and handling must comply with standard laser safety protocols for surgical devices.

Other devices from Inframed, Inc.