The following data is part of a premarket notification filed by Conair Corporation with the FDA for Lumilisse Ipl Hair Remover.
Device ID | K172791 |
510k Number | K172791 |
Device Name: | Lumilisse IPL Hair Remover |
Classification | Light Based Over-the-counter Hair Removal |
Applicant | Conair Corporation One Cummings Point Road Stamford, CT 06902 |
Contact | Mike Cantrell |
Correspondent | E.j. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
Product Code | OHT |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-15 |
Decision Date | 2018-01-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00074108368751 | K172791 | 000 |