The following data is part of a premarket notification filed by Kiierr International, Llc with the FDA for Kiierr 272 Laser, Kiierr 148 Laser.
| Device ID | K181878 |
| 510k Number | K181878 |
| Device Name: | Kiierr 272 Laser, Kiierr 148 Laser |
| Classification | Laser, Comb, Hair |
| Applicant | Kiierr International, LLC 863 East Downington Avenue Salt Lake City, UT 84105 -3211 |
| Contact | Michael Anderson |
| Correspondent | Raymond R. Blanche NST Consultants, Inc 641 Shunpike Road, Suite 311 Chatham, NJ 07928 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-13 |
| Decision Date | 2018-09-05 |
| Summary: | summary |