KTP Disc Kit
FDA 510(k) K905424 · Laserscope
510(k) numberK905424
Submission
- Device name
- KTP Disc Kit
- Applicant
- Laserscope
San Jose, CA, US - Received
- December 4, 1990
- Decision date
- March 4, 1991
- 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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| 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 |
|---|---|---|
| K062719 | Greenlight HPS Series Surgical Laser System & AccessoriesGEX · Traditional | 12/01/2006SE |
| K061646 | Laserscope Guided Delivery Device (GDD) Cystourethroscope & AccessoriesFBO · Traditional | 06/27/2006SE |
| K034011 | Gemini Surgical Laser System & AccessoriesGEX · Traditional | 03/30/2004SE |
| K024206 | Aura Isurgical Laser System & AccessoriesGEX · Traditional | 11/17/2003SE |
| K020021 | Lyra Surgical Laser System and Accessiories (Nd:Yag Configuration)GEX · Traditional | 07/02/2002SE |
| K010834 | Lyra Series Surgical Laser System & AccessoriesGEX · Traditional | 05/21/2001SE |
| K010284 | Lyra G Series Surgical Laser System (SL Series Q-Switched Nd:Yag Configuration)GEX · Traditional | 05/01/2001SE |
| K003765 | Lyra G Series Surgical Laser System (SL Series Q-Switched Nd:Yag Configuration)GEX · Traditional | 03/06/2001SE |
| K003147 | Lyra Series Surgical Laser System (SL Series, Nd:Yag Configuration)GEX · Traditional | 12/15/2000SE |
| K990718 | Orion Series Surgical Laser System (SL Seriesq-Switched Nd:Yag Configuration)GEX · Traditional | 03/08/2000SE |
Questions and answers
When was KTP Disc Kit cleared by the FDA?
KTP Disc Kit (K905424) received a 510(k) decision of Substantially Equivalent on March 4, 1991, 90 days after the submission was received.
What is the product code of K905424?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.