Megabeam Aspirating Endocular Probe
FDA 510(k) K952340 · Ceram Optec, Inc.
510(k) numberK952340
Submission
- Device name
- Megabeam Aspirating Endocular Probe
- Applicant
- Ceram Optec, Inc.
Washington, DC, US - Received
- May 19, 1995
- Decision date
- June 12, 1995
- 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…
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| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 09/02/2026SE |
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| 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.
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|---|---|---|
| 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 |
| K993911 | Ceralas D Diode Laser System, Model D15, D25,D50GEX · Traditional | 02/01/2000SE |
| 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 |
Questions and answers
When was Megabeam Aspirating Endocular Probe cleared by the FDA?
Megabeam Aspirating Endocular Probe (K952340) received a 510(k) decision of Substantially Equivalent on June 12, 1995, 24 days after the submission was received.
What is the product code of K952340?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.