510(k) K142833
- Device
- INTRAGen
- Applicant
- JEISYS MEDICAL, INC.
- 510(k) number
- K142833
- Product code
- OUH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-06-04
- Date received
- 2014-09-30
- Regulation
- 878.4400
- Classification name
- Skin Resurfacing Rf Applicator
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kyung Won Hwang
- Address
- 307 Daerung Techno Tower 8th, 481-11 Gasan-Dong, Geumchen-Gu Seoul KR 153-775 153-775
FDA Registration Numbers#
- 3008085016
- 1064858
- 3018242561
- 3007535734
- 3014656892
- 3030495752
- 3013917867
- 3043140693
- 3015506965
- 3006985163
- 3013602304
- 3031944951
- 3015151147
- 3012204368
- 3008729892
- 3033715699
- 3010363436
Source Documents#
Other 510(k) Records For Product Code OUH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150409 | VIVACE Electrosurgical System | Sung Hwan E&B Co.,Ltd | 2016-01-15 |
| K130501 | INTENSIF | Endymed Medical, Ltd. | 2014-03-13 |
| K120513 | GLOW BY ENDYMED | Endymed Medical, Ltd. | 2012-05-08 |
| K101510 | FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR | Endymed Medical, Ltd. | 2011-02-17 |
Legacy Summary#
summary
FDA Review#
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