Medilase System 2010L Laser Lithotriptor
FDA 510(k) K895837 · Medical Laser, Inc.
510(k) numberK895837
Submission
- Device name
- Medilase System 2010L Laser Lithotriptor
- Applicant
- Medical Laser, Inc.
Minneapolis, MN, US - Received
- October 3, 1989
- Decision date
- December 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K913136 | Laser Endoscope Disc Decompression KitsLRO · Traditional | 11/01/1991SESK |
| K912265 | Medilase Semi-Rigid Instrod Sheath Series AE1000FED · Traditional | 10/10/1991SE |
| K912447 | Series 5000 Endoscope Console Models 5100 and 5200FET · Traditional | 09/27/1991SE |
| K912089 | Modified Series 2100 EndoscopesODF · Traditional | 08/12/1991SE |
| K901464 | Medilase Series 2200 EndoscopeGCM · Traditional | 08/07/1990SE |
| K900894 | Medilase Series 2100 EndoscopeGCQ · Traditional | 06/22/1990SE |
| K900380 | Medilase 5010 Endoscope ConsoleFET · Traditional | 05/15/1990SE |
Questions and answers
When was Medilase System 2010L Laser Lithotriptor cleared by the FDA?
Medilase System 2010L Laser Lithotriptor (K895837) received a 510(k) decision of Substantially Equivalent on December 14, 1989, 72 days after the submission was received.
What is the product code of K895837?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.