The following data is part of a premarket notification filed by Cyden Limited with the FDA for Ipulse Smoothskin Hair Removal System.
| Device ID | K122280 |
| 510k Number | K122280 |
| Device Name: | IPULSE SMOOTHSKIN HAIR REMOVAL SYSTEM |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | CYDEN LIMITED 2001 PENNSYLANIA AVE SUITE 950 Washington, DC 20006 |
| Contact | Austin Speier |
| Correspondent | Austin Speier CYDEN LIMITED 2001 PENNSYLANIA AVE SUITE 950 Washington, DC 20006 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-30 |
| Decision Date | 2012-10-23 |
| Summary: | summary |