The Alma Soprano Titanium
FDA 510(k) K230371 · Alma Lasers, Inc.
510(k) numberK230371
Submission
- Device name
- The Alma Soprano Titanium
- Applicant
- Alma Lasers, Inc.
Buffalo Grove, IL, US - Received
- February 13, 2023
- Decision date
- February 22, 2023
- 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 |
| 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 |
|---|---|---|
| K251684 | Alma TED+ SystemOAP · Traditional | 06/05/2026SE |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesGEX · Traditional | 09/24/2025SE |
| K251230 | The Alma Hybrid Laser SystemGEX · Special | 05/21/2025SE |
| K243044 | Alma HarmonyGEX · Traditional | 04/11/2025SE |
| K233024 | Alma HarmonyGEX · Traditional | 02/08/2024SE |
| K230308 | Alma HarmonyGEX · Traditional | 03/01/2023SE |
| 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 The Alma Soprano Titanium cleared by the FDA?
The Alma Soprano Titanium (K230371) received a 510(k) decision of Substantially Equivalent on February 22, 2023, 9 days after the submission was received.
What is the product code of K230371?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.