Biolitec, Inc.

Medical device manufacturer in Grandville, MA.

28510(k) clearances
1PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K112013Evolve(R) HPD 980/1470NM Multiwavelength Diode LaserGEX · Traditional 01/13/2012SE
K112253Ceralas 147NM Diode Laser SystemGEX · Traditional 09/20/2011SE
K110080Radial-Emitting Shaped Fiber Optic Delivery SystemGEX · Traditional 02/24/2011SE
K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…GEX · Traditional 12/16/2010SE
K101712Endovascular Laer Vein System KitGEX · Traditional 10/27/2010SE
K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…GEX · Traditional 09/15/2010SE
K090164Ceralas Multiwavelength 980/1470NM Diode LaserGEX · Traditional 06/26/2009SE
K083682180W Cerelas D 980NM Diode Laser, Model D180GEX · Special 01/09/2009SE
K08222515W Ceralas D 1470NM Diode Laser, Model D1470GEX · Special 12/03/2008SE
K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980GEX · Special 10/24/2008SE
K081015Ceralas D 980NM Diode Laser, Models D15 and D25GEX · Traditional 07/08/2008SE
K07268250W Ceralas D 1950NM Diode LaserGEX · Traditional 04/18/2008SE
K07306315W Ceralas D 1470NM Diode LaserGEX · Traditional 02/27/2008SE
K072779Ceralas D 980NM Diode Laser, Models D15 and D25GEX · Traditional 01/24/2008SE
K072106150W Ceralas D 980NM Diode LaserGEX · Special 08/30/2007SE
K071295100W Ceralas D 980NM Diode LaserGEX · Traditional 05/16/2007SE
K060050Megabeam Sidefiber Fiber Optic Delivery SystemGEX · Traditional 01/23/2006SE
K050824100W Ceralas D 980 Laser System, Model D100GEX · Traditional 08/10/2005SE
K032864Ceralas D 810 Diode Laser System, Model D15GEX · Traditional 03/19/2004SE
K032863Ceralas D 980 Diode Laser System, Models D15, D25, D50GEX · Traditional 03/19/2004SE
K030700Ceralas D 10-60 810NM Laser System with Endo Laser Vein System KitGEX · Traditional 06/04/2003SE
K024088Ceralas D 980 Laser System with Endo Laser Vein System Kit, Model: D15 and D25GEX · Special 01/02/2003SE
K013691Ceralas D Diode Laser System, Model # D50GEX · Traditional 08/13/2002SE
K020835Ceralas D10-60 810NM Diode Laser, Modelceralas DIO-60GEX · Traditional 06/12/2002SE
K020099Mega Beam/Ceralas Nonsterile Collimating HandpieceGEX · Traditional 04/11/2002SE
K013193Mega Beam/Ceralas Nonsterile Collimating HandpieceGEX · Traditional 12/21/2001SE
K010804Megabeam/Ceralas Reuseable Handpiece and Disposable TipsGEX · Traditional 10/04/2001SE
K010689Megabeam/Ceralas Non Sterile Fiber Optic Laser Delivery Systems, Model 200,320,400 or…GEX · Traditional 05/18/2001SE

PMA approvals