Ceralas I Laser System

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

Full name

Ceralas I Laser

Generic Name

System, laser, photodynamic therapy

PMA Number

P050021 ↗

FDA Product Code

MVF

Device Class

Class III

Advisory Committee

Radiology

FDA Decision

APWD Approval withdrawn

• 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

• 100W Ceralas D 980 Laser System, Model D100

  Class II

  FDA 510(k) K050824 Active Cleared 10 Aug 2005

• 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

See all devices from Biolitec, Inc. →