The following data is part of a premarket notification filed by Chromogenex Technologies Ltd with the FDA for I-lipo, Models A00-1238 (230v), A00-1239 (120v).
| Device ID | K101366 |
| 510k Number | K101366 |
| Device Name: | I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | CHROMOGENEX TECHNOLOGIES LTD UNITS 1&2 HEOL RHOSYN, PARC DAFEN Llanelli, Carmarthenshire, GB Sa148qg |
| Contact | Peter R Bevan |
| Correspondent | Peter R Bevan CHROMOGENEX TECHNOLOGIES LTD UNITS 1&2 HEOL RHOSYN, PARC DAFEN Llanelli, Carmarthenshire, GB Sa148qg |
| Product Code | NUV |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-17 |
| Decision Date | 2010-09-17 |
| Summary: | summary |