Optilite Fiberoptic Delivery Systems
FDA 510(k) K902871 · Xintec Corporation
510(k) numberK902871
Submission
- Device name
- Optilite Fiberoptic Delivery Systems
- Applicant
- Xintec Corporation
Mountain View, CA, US - Received
- June 29, 1990
- Decision date
- September 24, 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…
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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 |
|---|---|---|
| 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 |
| K971912 | Protege Er:Yag Laser System and AccessoriesGEX · Traditional | 11/03/1997SE |
| 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 |
Questions and answers
When was Optilite Fiberoptic Delivery Systems cleared by the FDA?
Optilite Fiberoptic Delivery Systems (K902871) received a 510(k) decision of Substantially Equivalent on September 24, 1990, 87 days after the submission was received.
What is the product code of K902871?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.