Megabeam Reusable Fiber Optic Handpiece and Needles
FDA 510(k) K980389 · Ceram Optec, Inc.
510(k) numberK980389
Submission
- Device name
- Megabeam Reusable Fiber Optic Handpiece and Needles
- Applicant
- Ceram Optec, Inc.
Washington, DC, US - Received
- February 2, 1998
- Decision date
- July 29, 1998
- 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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| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
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| 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 |
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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 |
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| 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 |
| K981126 | Ceralas G Frequency Doubled ND: Yag Laser Systems, Ceralas G3GEX · Traditional | 06/25/1998SE |
Questions and answers
When was Megabeam Reusable Fiber Optic Handpiece and Needles cleared by the FDA?
Megabeam Reusable Fiber Optic Handpiece and Needles (K980389) received a 510(k) decision of Substantially Equivalent on July 29, 1998, 177 days after the submission was received.
What is the product code of K980389?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.