Protege Er:Yag Laser System and Accessories
FDA 510(k) K971912 · Xintec Corporation
510(k) numberK971912
Submission
- Device name
- Protege Er:Yag Laser System and Accessories
- Applicant
- Xintec Corporation
Oakland, CA, US - Received
- April 11, 1997
- Decision date
- November 3, 1997
- 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
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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 |
|---|---|---|
| K082230 | Vectra Plus Laser System and AccessoriesGEX · Traditional | 02/03/2010SE |
| K060114 | Vectra Laser SystemGEX · Traditional | 04/07/2006SE |
| K990914 | Polaris Diode Laser System and AccessoriesGEX · Traditional | 07/30/1999SE |
| K981627 | Protege II Er: Yag Laser System and Accessoies (Upgrade)GEX · Traditional | 07/31/1998SE |
| K981350 | Alexis Alexandrite Laser System and AccessoriesGEX · Traditional | 07/09/1998SE |
| K971065 | Dentica Pulsed ND: Yag Laser Systems and AccessoriesGEX · Traditional | 06/17/1997SE |
| K951935 | Prodigy Superpulse Nd:Yag Surgical Laser Systems & AccessoriesGEX · Traditional | 03/25/1996SE |
| K951876 | Protege Er:Yag Surgical Laser System and AccessoriesGEX · Traditional | 03/25/1996SE |
| K951910 | Odyssey Ho:Yag Surgical Laser Systems & AccessoriesGEX · Traditional | 12/27/1995SE |
| K951760 | Optilite Viii Laser Surgery AccessoriesGEX · Traditional | 11/29/1995SE |
Questions and answers
When was Protege Er:Yag Laser System and Accessories cleared by the FDA?
Protege Er:Yag Laser System and Accessories (K971912) received a 510(k) decision of Substantially Equivalent on November 3, 1997, 206 days after the submission was received.
What is the product code of K971912?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.