Data / Medical devices / China / Rejuva Fresh LLC
Rejuva Fresh LLC: FDA-registered device maker in Shenzhen Guangdong, China, 22 510(k) clearances
Rejuva Fresh LLC is registered with the FDA (registration 3033844600) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 22 510(k) clearances under its listings, the newest dated June 4, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3033844600
- Address
- Room 506, Block B, Shenzhen Duocai Huiwei Cultural and Creative Expo City No. 5010 Bao'an Avenue, Caowei Community, Hangcheng Street, Bao'an District, Shenzhen Guangdong, China, 518101
- Owner or operator
- Rejuva Fresh LLC (10091638)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 21, 2024
- Registered through
- 2026
- Brand names listed
- PlasmaMax Pro 8D Multi-Functional Cold & Hot, Light Goddess PRO Therapeutic Skin Revitalizer, REVIVO Dual Summit 1927/1550 Fractional Laser System, Rejuva 7D HIFU, Rejuva Fresh 15 in 1 Hydra Beauty, Rejuva Fresh 18 in 1 Hydra Spa Infusion Ultra Glow, Rejuva Fresh 360 Ultraformation HIFU, Rejuva Fresh 7 in 1 Hydro Dermabrasion, Rejuva Fresh APEX 10D Professional Intense Pulsed Light System; Rejuva Fresh Astral 10D and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Exporter to the US | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 4, 2026 | K260690 | LumiGlam Laser System (SHE-LSP601-3) | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| January 27, 2025 | K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1) | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| December 20, 2024 | K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | GEX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| September 17, 2024 | K242186 | Neo Sculptor (OF-NEO001) | NGX | Substantially Equivalent | Ofan Intelligent Technology (Guangzhou) Co. , Ltd. | accessdata.fda.gov |
| May 20, 2024 | K240474 | Multi-function Platform Systems (BL-M10) | GEX | Substantially Equivalent | Shanghai Bele Medical Technology Co.,Ltd | accessdata.fda.gov |
| February 6, 2024 | K233416 | Cryojet Plus (SHE-ACP001-1) | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| November 2, 2023 | K232532 | Nd:Yag Laser Therapy Systems | GEX | Substantially Equivalent | Beijing Unt Technology Co., Ltd. | accessdata.fda.gov |
| October 19, 2023 | K231749 | Radio Frequency System | GEI | Substantially Equivalent | Shenzhenshi Sincoheren S&T Development Co., Ltd. | accessdata.fda.gov |
| September 6, 2023 | K230024 | HI-EMT MAGSHAPE | NGX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| July 7, 2023 | K231318 | Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) | NGX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| December 9, 2022 | K222916 | US 450 Diode Laser Equipment | GEX | Substantially Equivalent | Beijing Globalipl Development Co., Ltd. | accessdata.fda.gov |
| August 23, 2022 | K220268 | Picosecond Laser System (Model PS10-A and PS10-B) | GEX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| August 12, 2022 | K220385 | Intense Pulsed Light Equipment | ONF | Substantially Equivalent | Beijing Globalipl Development Co., Ltd. | accessdata.fda.gov |
| February 1, 2022 | K212611 | CO2 Laser Equipment | GEX | Substantially Equivalent | Beijing Globalipl Development Co., Ltd. | accessdata.fda.gov |
| April 6, 2020 | K191970 | Diode Laser Hair Removal System | GEX | Substantially Equivalent | Beijing Sano Laser S&T Development Co.,Ltd | accessdata.fda.gov |
| April 3, 2020 | K192735 | Diode Laser Hair Removal Machine | GEX | Substantially Equivalent | Beijing Lead Beauty S & T Co., Ltd. | accessdata.fda.gov |
| March 25, 2020 | K193328 | IPL + Diode Laser Machine | ONF | Substantially Equivalent | Beijing Globalipl Development Co., Ltd. | accessdata.fda.gov |
| March 20, 2020 | K193609 | Q Switched Nd: YAG Laser machine | GEX | Substantially Equivalent | Beijing Lead Beauty S & T Co., Ltd. | accessdata.fda.gov |
| February 22, 2017 | K161926 | ND YAG Q-switch Laser Therapy Machine | GEX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| November 16, 2016 | K161692 | Diode Laser Therapy Machine | GEX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| October 5, 2016 | K161925 | CO2 Laser Therapy Machine | GEX | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
| August 4, 2016 | K161286 | IPL Therapy Machine | ONF | Substantially Equivalent | Beijing Adss Development Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Brush, Dermabrasion, Powered
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated June 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.