The following data is part of a premarket notification filed by Light Sources, Inc. with the FDA for Uv Lamps For Indoor Tanning Devices.
Device ID | K151370 |
510k Number | K151370 |
Device Name: | UV Lamps For Indoor Tanning Devices |
Classification | Booth, Sun Tan |
Applicant | LIGHT SOURCES, INC. 37 ROBINSON BLVD Orange, CT 06477 |
Contact | Eugene Czako |
Correspondent | Susan Anthony LIGHT SOURCES, INC. 37 Robinson Blvd Orange, CT 06477 |
Product Code | LEJ |
CFR Regulation Number | 878.4635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-21 |
Decision Date | 2015-12-17 |
Summary: | summary |