A-FIT

Hironic Co., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K173676
Device name
A-FIT
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

2

K173676 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K173676 as a predicate