Shenzhen Peninsula Medical Group
Manufacturer and brand owner in Shenzhen, Guangdong, China. 4 device types, 3 products catalogued, 2 clearances.
Shenzhen Peninsula Medical Group is a manufacturer holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument, Light, Ultraviolet, Dermatological and 2 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2025.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3016746323 |
| FEI number | 3016746323 |
| DUNS | 544317730 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳半岛医疗集团股份有限公司 |
|---|---|
| Unified social credit code | 91440300326482361T |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 101 1F Block B, 3F Block B, 3F Block A, Building F2, Changfeng industrial Park, Liuxian 3rd Road, 68# |
| Postal code | 518000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III), ZenTite | 2025 | 65 |
| Light, Ultraviolet, Dermatological | Class 2 | 308nm UV Phototherapy System, model UV-K, UV-X, UV-Y, UV-Z | 2025 | 8 |
| Massager, Vacuum, Radio Frequency Induced Heat | Class 2 | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III), ZenTite | 2025 | 13 |
| Powered Laser Surgical Instrument | Class 2 | Boston PICO, Boston 2910, Boston Pico755 | 2026 | 92 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Boston Aesthetics | GEI | 17 |
| Boston Aesthetics | FTC | 4 |
| Boston Aesthetics | GEX | 2 |
Clearances
2 clearances name Shenzhen Peninsula Medical Group as applicant. 5 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K254290 | 2026-01-30 | GEI | Special | This company |
| K202126 | 2021-06-08 | FXX | Traditional | This company |
| K253245 | 2026-05-21 | GEX | Traditional | Boston Aesthetics Inc |
| K251981 | 2026-01-30 | GEX | Traditional | Boston Aesthetics Inc |
| K252369 | 2026-01-21 | GEX | Traditional | Boston Aesthetics Inc |
| K244022 | 2025-03-13 | FTC | Traditional | Boston Aesthetics Inc |
| K241832 | 2025-02-13 | GEI | Traditional | Boston Aesthetics Inc |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Employees | 1000 |
| Main products | Focused ultrasound device, Radiofrequency microneedling device, Picosecond laser device, Pelvic floor rehabilitation device |
| Certifications | NMPA Class III, FDA |
| Export markets | 70+ countries globally |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.