Manufacturer
Hironic Co., Ltd.A-FIT
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K173676
- Device name
- A-FIT
- Company
- Hironic Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-11-30
- Decision date
- 2018-09-14
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Body contouring
- Primary application
- Body contouring
- Classification source
- AI classified
Indications for Use
The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. Main Hand piece for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia
Intended Use
The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. Main Hand piece for use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne, Treatment of atrophic acne scars, Treatment of facial wrinkles, Treatment of mild to moderate acne vulgaris, Treatment of Sebaceous Hyperplasia.
Device Description
A-FIT consists of Laser diode and high-frequency (RF) stimulator. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue. In addition, the RF energy can be used to relieve pain. Electrical Requirements: 115/230 VAC 50/60 Hz. Weight: 40 lbs (18 kg). Dimension: 17" H x 22" W x 20" D (431.8 x 558.8 x 508 mm). Operation time: 10 minutes.
Summary parsed at:2026-06-01 05:56:35 UTC
Predicate devices
2Cited as predicate
1NOABLE LASER
1 submission cite K173676 as a predicate
