The following data is part of a premarket notification filed by Cyden Limited with the FDA for Ipulse Smoothskin Gold Hair Removal Device.
Device ID | K160968 |
510k Number | K160968 |
Device Name: | IPulse SmoothSkin Gold Hair Removal Device |
Classification | Light Based Over-the-counter Hair Removal |
Applicant | CYDEN LIMITED TECHNIUM 2, KINGS ROAD Swansea, GB Sa1 8pj |
Contact | Mike Kiernan |
Correspondent | Mike Kiernan CYDEN LIMITED TECHNIUM 2, KINGS ROAD Swansea, 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 | 2016-04-06 |
Decision Date | 2016-04-14 |
Summary: | summary |