The following data is part of a premarket notification filed by Ipulse Limited with the FDA for Ipulse Smooth Skin Gold Hair Removal System.
| Device ID | K143003 |
| 510k Number | K143003 |
| Device Name: | IPulse Smooth Skin Gold Hair Removal System |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Ipulse Limited Technium 2, Kings Road, The Docks Swansea, GB Sa1 8pj |
| Contact | Mike Kiernan |
| Correspondent | Mike Kiernan Ipulse Limited Technium 2, Kings Road, The Docks Swansea, GB Sa1 8pj |
| Product Code | OHT |
| Subsequent Product Code | GEX |
| Subsequent Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-20 |
| Decision Date | 2015-06-18 |
| Summary: | summary |