The following data is part of a premarket notification filed by Jeisys Medical Inc with the FDA for Smoothcool Hr System.
| Device ID | K213484 |
| 510k Number | K213484 |
| Device Name: | SmoothCool HR System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Jeisys Medical Inc 307, 308, 401, Daeryung Techno Town 8th, 96, Gamasan-ro, Geumcheon-Gu Seoul, KR 08501 |
| Contact | Sang Hoon Hwang |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-29 |
| Decision Date | 2022-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800020102720 | K213484 | 000 |