A-FIT
Powered Laser Surgical Instrument
HIRONIC Co., Ltd.
The following data is part of a premarket notification filed by Hironic Co., Ltd. with the FDA for A-fit.
Pre-market Notification Details
| Device ID | K173676 |
| 510k Number | K173676 |
| Device Name: | A-FIT |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HIRONIC Co., Ltd. 19F, 767, Sinsu-ro, Suji-gu Gyeonggi-do, KR 16827 |
| Contact | Sangwon Hwang |
| Correspondent | Mina Joo BT Solutions, Inc. Unit 502, 148 Yeoksam-ro Seoul, KR 06249 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-30 |
| Decision Date | 2018-09-14 |
| Summary: | summary |
Trademark Results [A-FIT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 A-FIT 86728456 4955068 Live/Registered |
GC Corporation 2015-08-18 |
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