The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Heatlux Pro I.
| Device ID | K150175 |
| 510k Number | K150175 |
| Device Name: | HeatLux Pro I |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | HOME SKINOVATIONS LTD. Tabor Building, Shaar Yokneam Yoqneam Iillit, IL 2069200 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein A.Stein-Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, IL 4442520 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-26 |
| Decision Date | 2015-03-31 |
| Summary: | summary |