The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Heatlux.
| Device ID | K120582 |
| 510k Number | K120582 |
| Device Name: | HEATLUX |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | HOME SKINOVATIONS LTD. TAVOR BULD. POB 533 Yokneam Illit, IL 20692 |
| Contact | Amir Waldman, Ph.d |
| Correspondent | Amir Waldman, Ph.d HOME SKINOVATIONS LTD. TAVOR BULD. POB 533 Yokneam Illit, IL 20692 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-27 |
| Decision Date | 2012-07-06 |
| Summary: | summary |