The following data is part of a premarket notification filed by Jeisys Medical, Inc. with the FDA for Intracel Premium Fractional Rf Micro Needle (frm) System.
| Device ID | K153727 |
| 510k Number | K153727 |
| Device Name: | INTRAcel Premium Fractional RF Micro Needle (FRM) System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | JEISYS MEDICAL, INC. 307 Daeryung Techno Town 8th, Gamasan-ro 96, Geumcheon-Gu Seoul, KR 153-775 |
| Contact | Hyoseok Lee |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28800020101024 | K153727 | 000 |
| 08800020101013 | K153727 | 000 |