The following data is part of a premarket notification filed by Conversion Labs, Pr, Llc with the FDA for Shapiro Md Model Laser 272.
Device ID | K193667 |
510k Number | K193667 |
Device Name: | Shapiro MD Model Laser 272 |
Classification | Laser, Comb, Hair |
Applicant | Conversion Labs, PR, LLC 53 Calle Las Palmeras, Suite 802 San Juan, PR 00901 |
Contact | Stefan Galluppi |
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 | 2019-12-31 |
Decision Date | 2020-03-25 |