The following data is part of a premarket notification filed by Chromogenex Technologies Limited with the FDA for I-lipo System.
| Device ID | K111501 |
| 510k Number | K111501 |
| Device Name: | I-LIPO SYSTEM |
| Classification | Fat Reducing Low Level Laser |
| Applicant | CHROMOGENEX TECHNOLOGIES LIMITED UNITS 1& 2 HEOL RHOSYN PARC DAFEN INDUSTRIAL ESTATE Llanelli, Carmarthenshire, GB Sa14 8qg |
| Contact | Peter R Bevan |
| Correspondent | Peter R Bevan CHROMOGENEX TECHNOLOGIES LIMITED UNITS 1& 2 HEOL RHOSYN PARC DAFEN INDUSTRIAL ESTATE Llanelli, Carmarthenshire, GB Sa14 8qg |
| Product Code | OLI |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-31 |
| Decision Date | 2012-03-23 |
| Summary: | summary |