Sharplan CO2 Lasers, Model Numbers 1050 and 1075
FDA 510(k) K903230 · Sharplan Lasers, Inc.
510(k) numberK903230
Submission
- Device name
- Sharplan CO2 Lasers, Model Numbers 1050 and 1075
- Applicant
- Sharplan Lasers, Inc.
Allendale, NJ, US - Received
- July 23, 1990
- Decision date
- October 11, 1990
- 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…
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 CO2 Lasers, Model Numbers 1050 and 1075 cleared by the FDA?
Sharplan CO2 Lasers, Model Numbers 1050 and 1075 (K903230) received a 510(k) decision of Substantially Equivalent on October 11, 1990, 80 days after the submission was received.
What is the product code of K903230?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.