The following data is part of a premarket notification filed by Viora Ltd. with the FDA for Reaction System.
| Device ID | K090221 |
| 510k Number | K090221 |
| Device Name: | REACTION SYSTEM |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | VIORA LTD. 30 MONTGOMERY STREET SUITE 660 Jersey City, NJ 07302 |
| Contact | Josef Luzon |
| Correspondent | Josef Luzon VIORA LTD. 30 MONTGOMERY STREET SUITE 660 Jersey City, NJ 07302 |
| Product Code | NUV |
| Subsequent Product Code | ILY |
| Subsequent Product Code | ISA |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-30 |
| Decision Date | 2009-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016746334 | K090221 | 000 |
| 07290016746327 | K090221 | 000 |
| 07290016746310 | K090221 | 000 |
| 07290016746303 | K090221 | 000 |