The following data is part of a premarket notification filed by Cosmedico Light, Inc. with the FDA for Ultraviolet Lamps Intended For Use In Sunlamp Products (commonly Known As Metal Halide Sunlamps).
| Device ID | K152095 |
| 510k Number | K152095 |
| Device Name: | Ultraviolet Lamps Intended For Use In Sunlamp Products (commonly Known As Metal Halide Sunlamps) |
| 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 | 2015-07-28 |
| Decision Date | 2015-10-28 |
| Summary: | summary |