Surgi Light Non-Contact Fibers
FDA 510(k) K914396 · Lifestream Int'L, Inc.
510(k) numberK914396
Submission
- Device name
- Surgi Light Non-Contact Fibers
- Applicant
- Lifestream Int'L, Inc.
The Woodlands, TX, US - Received
- October 1, 1991
- Decision date
- December 23, 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…
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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 |
|---|---|---|
| K964571 | Vision Cardioplegia Delivery SystemDTR · Traditional | 08/08/1997SE |
| K962354 | Diomed 15, 30, 60 Surgical Diode LaserGEX · Traditional | 09/11/1996SE |
| K920178 | Cardiotomy Reservoir W/20 Micron FiliterDTN · Traditional | 05/13/1993SE |
| K920618 | Autotransfusion Suction SetCAC · Traditional | 03/12/1993SE |
| K913181 | Autologous Blood Processing SystemCAC · Traditional | 05/20/1992SE |
| K912045 | TMP Pressure Isolatorr, TMP Pressure Monitor SystDXS · Traditional | 10/31/1991SE |
| K911523 | Modification to Model 90-1460 Laser AdapterGEX · Traditional | 04/22/1991SE |
| K910726 | Light-Touch and Surgi Light FibersGEX · Traditional | 03/29/1991SE |
| K904491 | TMP Left Atrial Pressure Cath Cat.# 100-00X-000DQO · Traditional | 02/01/1991SE |
| K903709 | Surgimedics, SLP Laparoscopic Cholangiogram CathGBZ · Traditional | 10/26/1990SE |
Questions and answers
When was Surgi Light Non-Contact Fibers cleared by the FDA?
Surgi Light Non-Contact Fibers (K914396) received a 510(k) decision of Substantially Equivalent on December 23, 1991, 83 days after the submission was received.
What is the product code of K914396?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.