The following data is part of a premarket notification filed by Medtek Lighting Corp D/b/a Peacock Tanning with the FDA for Peacock Tanning, Express Tan Models 1000ht/1600ht/2000ct/2000ht/3200.
| Device ID | K152452 |
| 510k Number | K152452 |
| Device Name: | Peacock Tanning, EXPRESS TAN Models 1000HT/1600HT/2000CT/2000HT/3200 |
| Classification | Booth, Sun Tan |
| Applicant | MEDTEK LIGHTING CORP D/B/A PEACOCK TANNING 3 DEPOT STREET Hudson Falls, NY 12839 |
| Contact | Gary Richardson |
| Correspondent | Susan Anthoney-dewet AEGIS REGULATORY, INC. 2424 DEMPSTER DRIVE Coralville, IA 52241 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-28 |
| Decision Date | 2016-05-19 |
| Summary: | summary |