Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode Laser Family, Ceralas Hpd/ 980NM

FDA 510(k) K100726 · Biolitec, Inc.

Substantially Equivalent

510(k) numberK100726

Submission

Device name
Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode Laser Family, Ceralas Hpd/ 980NM
Applicant
Biolitec, Inc.
Grandville, MA, US
Received
March 15, 2010
Decision date
September 15, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GEX – Powered Laser Surgical Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4810
Specialty
General, Plastic Surgery

A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…

Other 510(k)s with product code GEX

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K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)GEX · Traditional Wuhan Pioon Technology Co., Ltd.09/10/2026SE
K261562Diode Laser Therapy SystemGEX · Traditional Sanhe LEFIS Electronics Co., Ltd.09/10/2026SE
K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)GEX · Traditional Zhengzhou PZ Laser Slim Technology Co., Ltd.09/02/2026SE
K262269CO2 Laser System (MBT- CO2 Laser)GEX · Traditional Beijing Mega Beauty Technology Co., Ltd.09/01/2026SE
K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX · Traditional Zhengzhou PZ Laser Slim Technology Co., Ltd.08/27/2026SE
K262070Diode Laser Therapy Systems (DL612A)GEX · Traditional Hebei Zollvan Medical Technology Co., Ltd.08/19/2026SE
K261964Echolaser X4GEX · Traditional Elesta S.P.A08/19/2026SE
K261841Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional Beijing Nubway S&T Co., Ltd.08/11/2026SE
K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…GEX · Traditional Olympus Surgical Technologies America07/24/2026SE
K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)GEX · Traditional Rhein Laser Technologies Co., Ltd.07/21/2026SE

More from Rhein Laser Technologies Co., Ltd.

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
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

Questions and answers

When was Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode Laser Family, Ceralas Hpd/ 980NM cleared by the FDA?

Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode Laser Family, Ceralas Hpd/ 980NM (K100726) received a 510(k) decision of Substantially Equivalent on September 15, 2010, 184 days after the submission was received.

What is the product code of K100726?

The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.