Cilas Model YM101

FDA 510(k) K852761 · Inframed, Inc.

Substantially Equivalent

510(k) numberK852761

Submission

Device name
Cilas Model YM101
Applicant
Inframed, Inc.
Brookline Village, MA, US
Received
June 28, 1985
Decision date
November 14, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LLO – Laser, Neodymium:Yag, Pulmonary Surgery
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4500
Specialty
Ear, Nose, Throat

Other 510(k)s with product code LLO

510(k)DeviceApplicantDecision
K884815SLT CLMD Contact LaserLLO · Traditional Surgical Laser Technologies, Inc.12/22/1988SE
K881499Surgilase Yag 100 for Gynecology UseLLO · Traditional Surgilase, Inc.04/29/1988SE
K880592Laseguide 600A, 600B, 400A, 400B for Pulmonary UseLLO · Traditional Laser Peripherals, LLC04/25/1988SE
K880170Model 4900 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional Cooper Lasersonics, Inc.03/24/1988SE
K874254Nd:Yag Surgical Laser for Pulmonary ApplicationsLLO · Traditional Minnesota Laser Corp.03/04/1988SE
K875104Surgi-Light Disposable System for Pulmonology UseLLO · Traditional Laserguide02/02/1988SE
K871876Model 5050 Surgilaser for Pulmonary UseLLO · Traditional Lasermatic, Inc.01/22/1988SE
K872351Fiberlase II Nd:Yag Laser for Pulmonary UseLLO · Traditional Laser Media12/11/1987SE
K870505Optilase Yag Model 1000 Surg Laser Sys/Pulmon ApplLLO · Traditional Trimedyne, Inc.08/07/1987SE
K871511SL-100 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional Medical Energy, Inc.07/21/1987SE

More from Medical Energy, Inc.

510(k)DeviceDecision
K864610Cilas Ym 101 Nd:Yag Laser for Neurological UseLLF · Traditional 06/18/1987SE
K844178Model TT25RFGEX · Traditional 10/18/1985SE

Questions and answers

When was Cilas Model YM101 cleared by the FDA?

Cilas Model YM101 (K852761) received a 510(k) decision of Substantially Equivalent on November 14, 1985, 139 days after the submission was received.

What is the product code of K852761?

The FDA product code is LLO – Laser, Neodymium:Yag, Pulmonary Surgery, a Class II (moderate risk) device regulated under 21 CFR 874.4500.