AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
FDA 510(k) K202428 · Lumenis, Ltd.
510(k) numberK202428
Submission
- Device name
- AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
- Applicant
- Lumenis, Ltd.
Yokneam, IL - Received
- August 25, 2020
- Decision date
- October 22, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K211979 | Lumenis Y&R Laser SystemGEX · Traditional | 06/21/2022SE |
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and AccessoriesGEX · Traditional | 10/19/2021SE |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesGEX · Special | 12/24/2020SE |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesGEX · Special | 07/16/2020SE |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemGEX · Special | 01/16/2020SE |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOGEX · Special | 04/03/2018SE |
| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityGEX · Traditional | 09/18/2017SE |
| K170060 | M22 and ResurFx SystemsGEX · Special | 08/09/2017SE |
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesGEX · Special | 05/22/2017SE |
| K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus…GEX · Traditional | 02/28/2017SE |
Questions and answers
When was AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories cleared by the FDA?
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (K202428) received a 510(k) decision of Substantially Equivalent on October 22, 2020, 58 days after the submission was received.
What is the product code of K202428?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.