The following data is part of a premarket notification filed by Gowoonsesang Cosmetics Co., Ltd with the FDA for Ga-b, Ga-c, Ga-e, Ga-i, Ga-s, Ga-w3a, Ga-f3a, Ga-il, Ga-sl, Ga-w3b, Ga-f1a.
| Device ID | K171707 |
| 510k Number | K171707 |
| Device Name: | GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Gowoonsesang Cosmetics Co., Ltd (Seohyeon-dong, 4, 5F Cocoplaza) 20, Seohyeon-ro 210beon-gil, Bundang-gu Seongnam-si, KR 13591 |
| Contact | Kyeong Tai Ko |
| Correspondent | Dongha Lee KMC, Inc. Room No. 904, 27, Digital-ro 27ga-gil Guro-gu Seoul, KR 08375 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-08 |
| Decision Date | 2017-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800067700139 | K171707 | 000 |
| 18800067700030 | K171707 | 000 |
| 18800067700047 | K171707 | 000 |
| 18800067700054 | K171707 | 000 |
| 18800067700061 | K171707 | 000 |
| 18800067700078 | K171707 | 000 |
| 18800067700085 | K171707 | 000 |
| 18800067700092 | K171707 | 000 |
| 18800067700108 | K171707 | 000 |
| 18800067700115 | K171707 | 000 |
| 18800067700122 | K171707 | 000 |
| 18800067700023 | K171707 | 000 |