Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
FDA 510(k) K250071 · Alma Lasers, Inc.
Submission
- Device name
- Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
- Applicant
- Alma Lasers, Inc.
Buffalo Grove, IL, US - Received
- January 10, 2025
- Decision date
- September 24, 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…
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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.
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| K243044 | Alma HarmonyGEX · Traditional | 04/11/2025SE |
| K233024 | Alma HarmonyGEX · Traditional | 02/08/2024SE |
| K230308 | Alma HarmonyGEX · Traditional | 03/01/2023SE |
| K230371 | The Alma Soprano TitaniumGEX · Special | 02/22/2023SE |
| K222064 | The Alma Soprano TitaniumGEX · Traditional | 10/12/2022SE |
| K212073 | Alma Diode Tabletop LaserGEX · Traditional | 07/14/2022SE |
| K201520 | The Alma Opus System, Colibri Applicator and TipsGEI · Traditional | 10/27/2021SE |
| K203441 | The Alma Hybrid Laser SystemGEX · Traditional | 07/02/2021SE |
Questions and answers
When was Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories cleared by the FDA?
Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories (K250071) received a 510(k) decision of Substantially Equivalent on September 24, 2025, 257 days after the submission was received.
What is the product code of K250071?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.