Sharplan Sharplase Family of Handswitched Nd:Yag
FDA 510(k) K914089 · Sharplan Lasers, Inc.
510(k) numberK914089
Submission
- Device name
- Sharplan Sharplase Family of Handswitched Nd:Yag
- Applicant
- Sharplan Lasers, Inc.
Allendale, NJ, US - Received
- September 11, 1991
- Decision date
- December 6, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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…
Other 510(k)s with product code GEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K973354 | Sharplan Epitouch Alexandrite Laser System (5000)GEX · Traditional | 12/04/1997SE |
| K972099 | Sharplan Epitouch Ruby Laser SystemGEX · Traditional | 08/27/1997SE |
| K971874 | Sharplan Epitouch Alexandrite Laser System (5000)GEX · Traditional | 08/18/1997SE |
| K971648 | Sharplan Erbium: Yag Laser (4020)GEX · Traditional | 07/23/1997SE |
| K971743 | Sharplan CO2 Surgical Laser SystemGEX · Traditional | 07/18/1997SE |
| K962446 | Sharplan Ruby Laser SystemGEX · Traditional | 03/07/1997SE |
| K963229 | Sharplan Models 20C, 30C, and 40C CO2 LasersGEX · Traditional | 11/05/1996SE |
| K961935 | Sharplan Lasers, Inc. Silktouch CO2 Flash ScannerGEX · Traditional | 11/01/1996SE |
| K962974 | Sharplan Lasers, Inc. Af Acuspot Micromanipulator (713)GEX · Traditional | 08/21/1996SE |
| K961279 | Sharplan Lasers, Inc. Ruby Laser SystemGEX · Traditional | 06/18/1996SE |
Questions and answers
When was Sharplan Sharplase Family of Handswitched Nd:Yag cleared by the FDA?
Sharplan Sharplase Family of Handswitched Nd:Yag (K914089) received a 510(k) decision of Substantially Equivalent on December 6, 1991, 86 days after the submission was received.
What is the product code of K914089?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.