The following data is part of a premarket notification filed by Cyden Limited with the FDA for Ipulse Hair Removal System.
| Device ID | K130315 |
| 510k Number | K130315 |
| Device Name: | IPULSE HAIR REMOVAL SYSTEM |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | CYDEN LIMITED TECHNIUM 2, KINGS ROAD Swansea, West Glamorgan, GB Sa1 8pj |
| Contact | David Broderick |
| Correspondent | David Broderick CYDEN LIMITED TECHNIUM 2, KINGS ROAD Swansea, West Glamorgan, GB Sa1 8pj |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-08 |
| Decision Date | 2013-07-12 |
| Summary: | summary |