Ceralas D 980NM Diode Laser, Models D15 and D25
FDA 510(k) K081015 · Biolitec, Inc.
510(k) numberK081015
Submission
- Device name
- Ceralas D 980NM Diode Laser, Models D15 and D25
- Applicant
- Biolitec, Inc.
Washington, DC, US - Received
- April 9, 2008
- Decision date
- July 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 09/10/2026SE |
| K261562 | Diode Laser Therapy SystemGEX · Traditional | Sanhe LEFIS Electronics Co., Ltd. | 09/10/2026SE |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 09/02/2026SE |
| K262269 | CO2 Laser System (MBT- CO2 Laser)GEX · Traditional | Beijing Mega Beauty Technology Co., Ltd. | 09/01/2026SE |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 08/27/2026SE |
| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
| K261964 | Echolaser X4GEX · Traditional | Elesta S.P.A | 08/19/2026SE |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 08/11/2026SE |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | Olympus Surgical Technologies America | 07/24/2026SE |
| K261738 | Medical 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) | Device | Decision |
|---|---|---|
| K112013 | Evolve(R) HPD 980/1470NM Multiwavelength Diode LaserGEX · Traditional | 01/13/2012SE |
| K112253 | Ceralas 147NM Diode Laser SystemGEX · Traditional | 09/20/2011SE |
| K110080 | Radial-Emitting Shaped Fiber Optic Delivery SystemGEX · Traditional | 02/24/2011SE |
| K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…GEX · Traditional | 12/16/2010SE |
| K101712 | Endovascular Laer Vein System KitGEX · Traditional | 10/27/2010SE |
| K100726 | Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…GEX · Traditional | 09/15/2010SE |
| K090164 | Ceralas Multiwavelength 980/1470NM Diode LaserGEX · Traditional | 06/26/2009SE |
| K083682 | 180W Cerelas D 980NM Diode Laser, Model D180GEX · Special | 01/09/2009SE |
| K082225 | 15W Ceralas D 1470NM Diode Laser, Model D1470GEX · Special | 12/03/2008SE |
| K082263 | Ceralas E 980NM Diode Laser, Models E15/980 and E30/980GEX · Special | 10/24/2008SE |
Questions and answers
When was Ceralas D 980NM Diode Laser, Models D15 and D25 cleared by the FDA?
Ceralas D 980NM Diode Laser, Models D15 and D25 (K081015) received a 510(k) decision of Substantially Equivalent on July 8, 2008, 90 days after the submission was received.
What is the product code of K081015?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.