The following data is part of a premarket notification filed by Capillus, Llc with the FDA for Capillus 272 Pro.
Device ID | K143199 |
510k Number | K143199 |
Device Name: | Capillus 272 Pro |
Classification | Laser, Comb, Hair |
Applicant | Capillus, LLC 1430 South Dixie Highway, Suite 304 Coral Gables, FL 33146 |
Contact | Frances Pina Brea |
Correspondent | Patricia Schnoor Capillus LLC 1430 South Dixie Hwy Suite 304 Coral Gables, FL 33146 |
Product Code | OAP |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-06 |
Decision Date | 2015-01-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00853327006190 | K143199 | 000 |
00853327006183 | K143199 | 000 |