LightWalker Laser System Family
FDA 510(k) K202985 · Fotona D.O.O.
510(k) numberK202985
Submission
- Device name
- LightWalker Laser System Family
- Applicant
- Fotona D.O.O.
Ljubljana, SI - Received
- September 30, 2020
- Decision date
- March 19, 2021
- 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…
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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 |
|---|---|---|
| K241785 | StarFormer (M008-3T)QPL · Traditional | 03/27/2025SE |
| K242202 | LightWalker Laser System FamilyGEX · Special | 08/23/2024SE |
| K234061 | StarFormerKPI · Traditional | 07/01/2024SE |
| K221274 | StarFormer, TightWaveIPF · Traditional | 09/29/2023SE |
| K223540 | AvalancheLase FamilyGEX · Traditional | 01/19/2023SE |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)GEX · Traditional | 10/12/2022SE |
| K213267 | Dynamis Pro FamilyGEX · Traditional | 09/08/2022SE |
| K202991 | Fotona XPulse Pro Laser PlatformGEX · Traditional | 06/22/2021SE |
| K202172 | StarWalkerGEX · Traditional | 11/19/2020SE |
| K193656 | SkyPulseGEX · Traditional | 03/27/2020SE |
Questions and answers
When was LightWalker Laser System Family cleared by the FDA?
LightWalker Laser System Family (K202985) received a 510(k) decision of Substantially Equivalent on March 19, 2021, 170 days after the submission was received.
What is the product code of K202985?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.