The following data is part of a premarket notification filed by Cosmedico Light, Inc with the FDA for Cosmedico Ultraviolet Lamps Of Various Models.
Device ID | K152273 |
510k Number | K152273 |
Device Name: | Cosmedico Ultraviolet Lamps Of Various Models |
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 | 2015-08-12 |
Decision Date | 2015-10-30 |
Summary: | summary |