Ceralas D Diode Laser System, Model D15, D25,D50
FDA 510(k) K993911 · Ceram Optec, Inc.
510(k) numberK993911
Submission
- Device name
- Ceralas D Diode Laser System, Model D15, D25,D50
- Applicant
- Ceram Optec, Inc.
East Longmeadow, MA, US - Received
- November 16, 1999
- Decision date
- February 1, 2000
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K002296 | Ceralas G15 532NM Frequency Doubled Nd:Yag Laser, Model G1-G15GEX · Traditional | 10/02/2000SE |
| K001975 | Ceralas D10 810NM Laser, Model Ceralas D10-60GEX · Traditional | 08/04/2000SE |
| K993828 | Ceralas D10 810NM Diode LaserGEX · Traditional | 02/01/2000SE |
| K993002 | Ceralas D 980NM Diode Laser System, Model D15GEX · Traditional | 10/14/1999SE |
| K992773 | Ceralas D10 810NM Diode LaserGEX · Traditional | 09/01/1999SE |
| K991891 | Ceralas Diode Laser System, Model Ceralas D15GEX · Traditional | 06/24/1999SE |
| K983950 | Ceralas Diode Laser System (Model H)GEX · Traditional | 02/03/1999SE |
| K983058 | Ceralas D Laser System, Model # Ceralas D15GEX · Traditional | 10/21/1998SE |
| K980389 | Megabeam Reusable Fiber Optic Handpiece and NeedlesGEX · Traditional | 07/29/1998SE |
| K981126 | Ceralas G Frequency Doubled ND: Yag Laser Systems, Ceralas G3GEX · Traditional | 06/25/1998SE |
Questions and answers
When was Ceralas D Diode Laser System, Model D15, D25,D50 cleared by the FDA?
Ceralas D Diode Laser System, Model D15, D25,D50 (K993911) received a 510(k) decision of Substantially Equivalent on February 1, 2000, 77 days after the submission was received.
What is the product code of K993911?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.