Data / Medical devices / China / Shenzhen Peninsula Medical Group
Shenzhen Peninsula Medical Group: FDA-registered device maker in Shenzhen Guangdong, China, 6 510(k) clearances
Shenzhen Peninsula Medical Group is registered with the FDA (registration 3016746323) in Shenzhen Guangdong, China. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 21, 2026. Registered through 2027. FDA data exported November 3, 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
- 3016746323
- Address
- 101 1F Block B, 3F Block B, 3F Block A, Building F2, Changfeng industrial Park, Liuxian 3rd Road, 68# Xin an Street, Bao an District, Shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen Peninsula Medical Group (10065717)
- Roles
- Manufacturer
- First device listed
- March 12, 2025
- Registered through
- 2027
- Brand names listed
- 308nm UV Phototherapy System, model UV-K, UV-X, UV-Y, UV-Z, Boston 2910, Boston PICO, Boston Pico755, Multi Injector Needle; Model: InDerm 3A+, InDerm 3B+, InDerm 3C+, InDerm 3D+, Multi Injector Needle; Model: InDerm 3A, InDerm 3B, InDerm 3C, InDerm 3D, Multi Injector Needle; Model: InDerm 4A+, InDerm 4B+, InDerm 4C+, InDerm 4D+, Multi Injector Needle; Model: InDerm 4A, InDerm 4B, InDerm 4C, InDerm 4D and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Light, Ultraviolet, Dermatological | FTC | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 21, 2026 | K253245 | Boston 2910 (Boston 2910) | GEX | Substantially Equivalent | Boston Aesthetics, Inc. | accessdata.fda.gov |
| January 30, 2026 | K254290 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | GEI | Substantially Equivalent | Shenzhen Peninsula Medical Group | accessdata.fda.gov |
| January 30, 2026 | K251981 | Boston PICO (Boston PICO) | GEX | Substantially Equivalent | Boston Aesthetics, Inc. | accessdata.fda.gov |
| January 21, 2026 | K252369 | Boston Pico755 | GEX | Substantially Equivalent | Boston Aesthetics, Inc. | accessdata.fda.gov |
| March 13, 2025 | K244022 | 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) | FTC | Substantially Equivalent | Boston Aesthetics, Inc. | accessdata.fda.gov |
| February 13, 2025 | K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) | GEI | Substantially Equivalent | Boston Aesthetics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Powered Laser Surgical Instrument
- All makers of Light, Ultraviolet, Dermatological
Updated May 21, 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.