The following data is part of a premarket notification filed by Cosmedico Light, Inc. with the FDA for Various Brands Of Ultraviolet Lamps.
Device ID | K150778 |
510k Number | K150778 |
Device Name: | Various Brands Of Ultraviolet Lamps |
Classification | Booth, Sun Tan |
Applicant | COSMEDICO LIGHT, INC. 233 Libbey Industrial Parkway Weymouth, MA 02189 |
Contact | Steven Schlitt |
Correspondent | Steven Schlitt COSMEDICO LIGHT, INC. 233 Libbey Industrial Parkway Weymouth, MA 02189 |
Product Code | LEJ |
CFR Regulation Number | 878.4635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-25 |
Decision Date | 2015-05-29 |
Summary: | summary |