Optimas MAX System
FDA 510(k) K251632 · InMode , Ltd.
510(k) numberK251632
Submission
- Device name
- Optimas MAX System
- Applicant
- InMode , Ltd.
Yokneam Lillit, FR - Received
- May 28, 2025
- Decision date
- June 26, 2025
- 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…
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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 |
|---|---|---|
| K251254 | Ignite RF SystemGEI · Traditional | 01/15/2026SE |
| K242598 | DEFINE System (AG612444A)PBX · Special | 11/14/2024SE |
| K240780 | InMode RF SystemGEI · Traditional | 07/24/2024SE |
| K240017 | InMode System with the Morpheus8 90 ApplicatorGEI · Traditional | 06/13/2024SE |
| K233642 | InMode RF SystemGEI · Traditional | 03/20/2024SE |
| K231495 | The Evolve System with the Transform ApplicatorGEI · Traditional | 10/13/2023SE |
| K231790 | The InMode System with the Morpheus8 ApplicatorsGEI · Special | 07/20/2023SE |
| K221571 | InMode Multi-systemGEX · Special | 06/30/2022SE |
| K210877 | Evolve System with the T3 ApplicatorPBX · Traditional | 07/19/2021SE |
| K201285 | InMode Evolve System with the Tone ApplicatorIPF · Traditional | 03/05/2021SE |
Questions and answers
When was Optimas MAX System cleared by the FDA?
Optimas MAX System (K251632) received a 510(k) decision of Substantially Equivalent on June 26, 2025, 29 days after the submission was received.
What is the product code of K251632?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.