Manufacturer
Shenzhen Peninsula Medical GroupZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
Shenzhen Peninsula Medical Group
Country / Region:China (CN)Submission type:Special
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K254290
- Device name
- ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
- Country / Region
- China(CN)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-12-31
- Decision date
- 2026-01-30
- Submission type
- Special
- Technology type
- RF Generator(AI inferred)
- Clinical applications
- SurgeryPain ManagementOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The ZenTite is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The ZenTite is used for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.
Intended Use
The ZenTite is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The ZenTite is used for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.
Device Description
Since the previous 510(k) clearance, several modifications have been made to improve usability, workflow efficiency, and service support while maintaining the device's intended use, fundamental technology, and performance characteristics. These changes include: (1) addition of a parameter memory function to facilitate quicker treatment setup; (2) addition of adjustable negative-pressure levels for vacuum-assisted tips; (3) addition of optional wireless connectivity to support remote software and firmware updates, basic device location functions, and transmission of non-sensitive operational data; (4) update of the device trade name and corresponding user interface elements.
Summary parsed at:2026-06-19 23:54:13 UTC
Predicate devices
1Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
K254290 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K254290 as a predicate