Quadrostar 980
FDA 510(k) K060459 · Asclepion Laser Technologies GmbH
510(k) numberK060459
Submission
- Device name
- Quadrostar 980
- Applicant
- Asclepion Laser Technologies GmbH
Jena, DE - Received
- February 22, 2006
- Decision date
- March 20, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
|---|---|---|
| K261094 | YellowStarGEX · Special | 04/29/2026SE |
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| K240831 | MultiCut SoloGCJ · Special | 11/06/2024SE |
| K241600 | DermablateGEX · Special | 07/03/2024SE |
| K240816 | MeDioStarGEX · Special | 04/23/2024SE |
| K231876 | MultiPulse HoPLUSGEX · Traditional | 02/22/2024SE |
| K213597 | MultiCut SoloGCJ · Traditional | 01/18/2023SE |
| K213889 | PicoStarGEX · Traditional | 04/22/2022SE |
| K210634 | MCL 31 Dermablate SystemGEX · Traditional | 04/13/2022SE |
| K192483 | MeDioStarGEX · Special | 03/13/2020SE |
Questions and answers
When was Quadrostar 980 cleared by the FDA?
Quadrostar 980 (K060459) received a 510(k) decision of Substantially Equivalent on March 20, 2006, 26 days after the submission was received.
What is the product code of K060459?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.