Model 2100 Nd:Yag Surgical Laser Urological Indica

FDA 510(k) K861046 · Sharplan Industries, Inc.

Substantially Equivalent

510(k) numberK861046

Submission

Device name
Model 2100 Nd:Yag Surgical Laser Urological Indica
Applicant
Sharplan Industries, Inc.
Washington, DC, US
Received
March 18, 1986
Decision date
May 2, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LNK – Laser For Gastro-Urology Use
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4810
Specialty
General, Plastic Surgery

Other 510(k)s with product code LNK

510(k)DeviceApplicantDecision
K925395Technomed Pulsolith 4000 Laser SystemLNK · Traditional Teknomed, Inc.05/21/1993SE
K901723MDL-2000 LasertripterLNK · Traditional Candela Laser Corp.07/13/1990SE
K874255Nd:Yag Surgical Laser for Endo. Gastro/Uro. Appli.LNK · Traditional Minnesota Laser Corp.07/12/1988SE
K874253Nd:Yag Surgical Laser for Gastro/Urology Applica.LNK · Traditional Minnesota Laser Corp.07/12/1988SE
K880256Model 4060 N Nd:Yag Laser for Gastroenterology UseLNK · Traditional Sharplan Lasers, Inc.04/14/1988SE
K880193Model 4060 N Nd:Yag Laser for Urological UseLNK · Traditional Sharplan Lasers, Inc.04/14/1988SE
K875039Nd:Yag 100 Surgical Laser for Gastro. and UrologyLNK · Traditional Surgilase, Inc.04/13/1988SE
K880171Model 4900 Nd:Yag Laser for Gastro & Genitour ApplLNK · Traditional Cooper Lasersonics, Inc.04/11/1988SE
K871934Model 5050 Surgilaser for Gastro-Intestinal UseLNK · Traditional Lasermatic, Inc.03/25/1988SE
K871932Model 5050 Surgilaser for Urology UseLNK · Traditional Lasermatic, Inc.03/25/1988SE

More from Lasermatic, Inc.

510(k)DeviceDecision
K861044Model 2100 Nd:Yag Surgical Laser Neurosurgical IndGEX · Traditional 10/28/1986SE
K861047Model 2100 Nd:Yag Surgical Laser GastrointestinalLNK · Traditional 06/17/1986SE
K861045Model 2100 Nd:Yag Surgical Laser Pulmonary IndicatLLO · Traditional 04/23/1986SE

Questions and answers

When was Model 2100 Nd:Yag Surgical Laser Urological Indica cleared by the FDA?

Model 2100 Nd:Yag Surgical Laser Urological Indica (K861046) received a 510(k) decision of Substantially Equivalent on May 2, 1986, 45 days after the submission was received.

What is the product code of K861046?

The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.