LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k) K260690 · Beijing Sano Laser S&T Development Co.,Ltd
510(k) numberK260690
Submission
- Device name
- LumiGlam Laser System (SHE-LSP601-3)
- Applicant
- Beijing Sano Laser S&T Development Co.,Ltd
Beijing, CN - Received
- March 3, 2026
- Decision date
- June 4, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 08/11/2026SE |
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More from Rhein Laser Technologies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1)GEX · Traditional | 06/12/2025SE |
| K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1)GEX · Traditional | 01/27/2025SE |
| K233416 | Cryojet Plus (SHE-ACP001-1)GEX · Traditional | 02/06/2024SE |
| K230024 | Hi-Emt MagshapeNGX · Traditional | 09/06/2023SE |
| K191970 | Diode Laser Hair Removal SystemGEX · Traditional | 04/06/2020SE |
Questions and answers
When was LumiGlam Laser System (SHE-LSP601-3) cleared by the FDA?
LumiGlam Laser System (SHE-LSP601-3) (K260690) received a 510(k) decision of Substantially Equivalent on June 4, 2026, 93 days after the submission was received.
What is the product code of K260690?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.