The following data is part of a premarket notification filed by Jeisys Medical Inc. with the FDA for Intracel Rf Microneedle System.
| Device ID | K183284 |
| 510k Number | K183284 |
| Device Name: | INTRAcel RF Microneedle 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 | Sugun Lee |
| Correspondent | Parul Chansoria Elexes Medical Consulting 6494 Tralee Village Dr Dublin, CA 94568 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-26 |
| Decision Date | 2020-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800020100184 | K183284 | 000 |
| 08800020100177 | K183284 | 000 |