100W Ceralas D 980 Laser System, Model D100

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K050824 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Ceralas D 980 Diode Laser System, Models D15, D25, D50

  Class II

  FDA 510(k) K032863 Active Cleared 19 Mar 2004

• Ceralas D 810 Diode Laser System, Model D15

  Class II

  FDA 510(k) K032864 Active Cleared 19 Mar 2004

• Megabeam/Ceralas Non Sterile Fiber Optic Laser Delivery Systems, Model 200, 320, 400 Or 600UM

  Class II

  FDA 510(k) K010689 Active Cleared 18 May 2001

• Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas Hpd Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser

  Class II

  FDA 510(k) K102755 Active Cleared 16 Dec 2010

• Ceralas D Diode Laser System, Model # D50

  Class II

  FDA 510(k) K013691 Active Cleared 13 Aug 2002

• Ceralas Multiwavelength 980/1470NM Diode Laser

  Class II

  FDA 510(k) K090164 Active Cleared 26 Jun 2009

See all devices from Biolitec, Inc. →

• What is the Ceralas D 980 Laser System Model D100 used for?

  The Ceralas D 980 Laser System Model D100 is a powered laser surgical instrument used in various surgical procedures including endoscopic applications. It delivers laser energy to soft tissue via contact or non-contact modes.

• What are the specifications of the Ceralas D 980 Laser System?

  This is a 980 nm diode laser system with a maximum wattage of 100W and a beam divergence of 12.79. It can be used with delivery fibers of 0.22 NA or greater. The system is classified as a Class II device under product code GEX.

• What is the regulatory status of the Ceralas D 980 Laser System?

  The Ceralas D 980 Laser System Model D100 received FDA 510(k) clearance under K050824 on 2005-08-10. It is classified as substantially equivalent and is intended for use in general and plastic surgery applications.

• How is the Ceralas D 980 Laser System supplied?

  The device is supplied as a complete laser system including the main unit and is designed to work with various delivery fibers. The manufacturer is Biolitec, Inc., and the system is intended for professional use in clinical settings.