Model 2100 Nd:Yag Surgical Laser Pulmonary Indicat

Q: What is the product code of K861045?

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

FDA 510(k) K861045 · Sharplan Industries, Inc.

Substantially Equivalent

510(k) numberK861045

Submission

Device name: Model 2100 Nd:Yag Surgical Laser Pulmonary Indicat
Applicant: Sharplan Industries, Inc.
Washington, DC, US
Received: March 18, 1986
Decision date: April 23, 1986
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)	Device	Applicant	Decision
K884815	SLT CLMD Contact LaserLLO · Traditional	Surgical Laser Technologies, Inc.	12/22/1988SE
K881499	Surgilase Yag 100 for Gynecology UseLLO · Traditional	Surgilase, Inc.	04/29/1988SE
K880592	Laseguide 600A, 600B, 400A, 400B for Pulmonary UseLLO · Traditional	Laser Peripherals, LLC	04/25/1988SE
K880170	Model 4900 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional	Cooper Lasersonics, Inc.	03/24/1988SE
K874254	Nd:Yag Surgical Laser for Pulmonary ApplicationsLLO · Traditional	Minnesota Laser Corp.	03/04/1988SE
K875104	Surgi-Light Disposable System for Pulmonology UseLLO · Traditional	Laserguide	02/02/1988SE
K871876	Model 5050 Surgilaser for Pulmonary UseLLO · Traditional	Lasermatic, Inc.	01/22/1988SE
K872351	Fiberlase II Nd:Yag Laser for Pulmonary UseLLO · Traditional	Laser Media	12/11/1987SE
K870505	Optilase Yag Model 1000 Surg Laser Sys/Pulmon ApplLLO · Traditional	Trimedyne, Inc.	08/07/1987SE
K871511	SL-100 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional	Medical Energy, Inc.	07/21/1987SE

More from Medical Energy, Inc.

510(k)	Device	Decision
K861044	Model 2100 Nd:Yag Surgical Laser Neurosurgical IndGEX · Traditional	10/28/1986SE
K861047	Model 2100 Nd:Yag Surgical Laser GastrointestinalLNK · Traditional	06/17/1986SE
K861046	Model 2100 Nd:Yag Surgical Laser Urological IndicaLNK · Traditional	05/02/1986SE

Questions and answers

When was Model 2100 Nd:Yag Surgical Laser Pulmonary Indicat cleared by the FDA?

Model 2100 Nd:Yag Surgical Laser Pulmonary Indicat (K861045) received a 510(k) decision of Substantially Equivalent on April 23, 1986, 36 days after the submission was received.

What is the product code of K861045?

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