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
