Manufacturer
Boston Aesthetics, Inc.Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Device details
FDA 510(k) registration fields
- K number
- K241832
- Device name
- Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)
- Company
- Boston Aesthetics, Inc.
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2024-06-25
- Decision date
- 2025-02-13
- Submission type
- Traditional
- Technology type
- RF Generator(AI inferred)
- Clinical applications
- SurgeryPain ManagementOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The Unicorn+ RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The RF System is used for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.
Intended Use
The Unicorn+ RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The RF System is used for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.
Device Description
Unicorn+ RF System consists of a host, a trolley, a footswitch, a power cord, three kinds of handpieces and matched electrodes.
Summary parsed at:2026-06-20 17:45:09 UTC
Predicate devices
6Cited as predicate
2Boston iFace (Boston iFace)
ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
2 submissions cite K241832 as a predicate