WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
FDA 510(k) K241643 · Wontech Co., Ltd.
510(k) numberK241643
Submission
- Device name
- WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
- Applicant
- Wontech Co., Ltd.
Daejeon, KR - Received
- June 7, 2024
- Decision date
- February 14, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K252877 | SANDRO DualGEX · Traditional | 12/19/2025SE |
| K250165 | PastelleGEX · Traditional | 07/03/2025SE |
| K251288 | VeincareGEX · Special | 05/14/2025SE |
| K251094 | Alma VeilGEX · Special | 05/06/2025SE |
| K243957 | PicoalexGEX · Traditional | 03/12/2025SE |
| K241527 | Pastelle ProGEX · Traditional | 02/14/2025SE |
| K243929 | Oligio XGEI · Special | 01/21/2025SE |
| K241930 | VeincareGEX · Traditional | 11/14/2024SE |
| K241406 | LavieenGEX · Traditional | 06/28/2024SE |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY)GEX · Traditional | 06/24/2024SE |
Questions and answers
When was WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) cleared by the FDA?
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) (K241643) received a 510(k) decision of Substantially Equivalent on February 14, 2025, 252 days after the submission was received.
What is the product code of K241643?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.