AviClear Laser System
FDA 510(k) K251149 · Cutera, Inc.
510(k) numberK251149
Submission
- Device name
- AviClear Laser System
- Applicant
- Cutera, Inc.
Brisbane, CA, US - Received
- April 14, 2025
- Decision date
- July 11, 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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| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 09/10/2026SE |
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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 |
|---|---|---|
| K233237 | xeo+ FamilyGEX · Traditional | 12/15/2023SE |
| K230660 | AviClear Laser SystemGEX · Traditional | 06/06/2023SE |
| K223110 | truSculpt iDGEI · Special | 11/03/2022SE |
| K221407 | truSculpt iDGEI · Traditional | 07/13/2022SE |
| K213461 | AviClear Laser SystemGEX · Traditional | 03/24/2022SE |
| K182997 | enlighten III Laser SystemGEX · Traditional | 12/12/2018SE |
| K180709 | truSculpt RF Device; truSculpt; truSculpt 3DPBX · Traditional | 06/06/2018SE |
| K172077 | Cutera enlighten III Laser SystemGEX · Traditional | 10/27/2017SE |
| K172004 | truSculptPBX · Special | 08/02/2017SE |
| K170936 | Cutera enlighten III Laser SystemGEX · Special | 04/25/2017SE |
Questions and answers
When was AviClear Laser System cleared by the FDA?
AviClear Laser System (K251149) received a 510(k) decision of Substantially Equivalent on July 11, 2025, 88 days after the submission was received.
What is the product code of K251149?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.