Manufacturer
ShenB Co., Ltd.Sunny
Country / Region:Korea, Republic of (KR)Submission type:Traditional
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
- K242241
- Device name
- Sunny
- Company
- ShenB Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2024-07-31
- Decision date
- 2025-03-19
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryPain ManagementOther
- Primary application
- Pain Management
- Classification source
- AI classified
Indications for Use
The Sunny RF Handpiece (6.78MHz) is indicated for Dermatologic procedures for electrocoagulation and hemostasis. The Pulsar handpiece (1MHz and 2MHz RF) is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
Intended Use
The Sunny RF Handpiece (6.78MHz) is indicated for Dermatologic procedures for electrocoagulation and hemostasis. The Pulsar handpiece (1MHz and 2MHz RF) is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
Device Description
The Sunny device is a high frequency electrosurgical unit that conveys current to the human body through non-invasive electrodes. The device includes three different high frequencies: 6.78MHz (RF), 1MHz (RF), and 2 MHz (RF). It is composed of the main body, Sunny handpiece, Pulsar handpiece, treatment tips, neutral electrode pad, refrigerant gas, and foot switch. The device is operated through a graphic user interface on an LCD screen and is intended to be operated by medical professionals.
Summary parsed at:2026-06-20 17:45:14 UTC