INTRAGen
Skin Resurfacing Rf Applicator
JEISYS MEDICAL, INC.
The following data is part of a premarket notification filed by Jeisys Medical, Inc. with the FDA for Intragen.
Pre-market Notification Details
| Device ID | K142833 |
| 510k Number | K142833 |
| Device Name: | INTRAGen |
| Classification | Skin Resurfacing Rf Applicator |
| Applicant | JEISYS MEDICAL, INC. 307 DAERUNG TECHNO TOWER 8TH, 481-11 GASAN-DONG, GEUMCHEN-GU Seoul, KR 153-775 |
| Contact | Kyung Won Hwang |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
| Product Code | OUH |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-06-04 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800020101218 | K142833 | 000 |
| 8800020105035 | K142833 | 000 |
Trademark Results [INTRAGen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTRAGEN 78439111 not registered Dead/Abandoned |
Ladalla, Anil J. 2004-06-22 |
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