MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS - 320

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

510(k) Number

K010689 ↗

FDA Product Code

GEX

Models / Variants

200

320

400 Or 600UM

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

• 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

• Ceralas Multiwavelength 980/1470NM Diode Laser

  Class II

  FDA 510(k) K090164 Active Cleared 26 Jun 2009

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• What is the purpose of the Megabeam/Ceralas delivery system?

  These fiber optic systems are designed to facilitate the transmission of laser energy during medical procedures, acting as the delivery component between the laser source and the treatment site.

• Are these delivery systems provided in a sterile state?

  No, the Megabeam/Ceralas fiber optic laser delivery systems are supplied non-sterile. Users must follow appropriate clinical protocols for sterilization or preparation prior to use in a medical procedure.

• What model sizes are available for this device?

  The delivery systems are available in four distinct fiber core diameters: 200um, 320um, 400um, and 600um, allowing clinicians to select the appropriate size for their specific laser application.

• What is the regulatory status of these laser delivery systems?

  The Megabeam/Ceralas fiber optic laser delivery systems have received FDA 510k clearance under the number K010689, confirming they have been found substantially equivalent to legally marketed predicate devices.