Product code OUH
- Device name
- Skin Resurfacing Rf Applicator
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4400
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Skin resurfacing
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150409 | VIVACE Electrosurgical System | Sung Hwan E&B Co.,Ltd | 2016-01-15 |
| K142833 | INTRAGen | Jeisys Medical, Inc. | 2015-06-04 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800016903706 | Secret PRO Articulated Arm | CLASSYS Inc. | 2024-10-31 |
| 08800016903690 | Secret PRO Main Unit | CLASSYS Inc. | 2024-10-31 |
| 08800016903683 | Secret PRO Set Package | CLASSYS Inc. | 2024-10-31 |
| 08800016903669 | Fraxis Duo Needle Handpiece | CLASSYS Inc. | 2024-10-30 |
| 08800016903652 | Fraxis Duo Scanner Handpiece | CLASSYS Inc. | 2024-10-30 |
| 08800016903645 | Fraxis Duo Articulated arm | CLASSYS Inc. | 2024-10-30 |
| 08800016903638 | Fraxis Duo Main Unit | CLASSYS Inc. | 2024-10-30 |
| 08800016903621 | Fraxis DUO Set Package | CLASSYS Inc. | 2024-10-30 |
| 08800016903331 | Secret RF Small Handpiece | CLASSYS Inc. | 2024-10-30 |
| 08800016903317 | Secret RF Smartcure Applicator With Electrodes | CLASSYS Inc. | 2024-10-30 |
| 08800016903300 | Secret RF Bigger Handpiece | CLASSYS Inc. | 2024-10-30 |
| 08800016903294 | Secret RF Main Unit | CLASSYS Inc. | 2024-10-30 |
| 08800016903195 | Fraxis Duo 25Pin Needle Tip | CLASSYS Inc. | 2024-10-30 |
| 08800016903287 | Secret RF Set Package | CLASSYS Inc. | 2024-10-25 |
| G055ABMVIVU010 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM010 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVS020 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVS010 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVR010 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM121 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM111 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM100 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM090 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM081 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM071 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM060 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM050 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM041 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM031 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |
| G055ABMVIVM020 | VIVACE ULTRA | Aesthetics Biomedical, Inc. | 2022-12-30 |