The following data is part of a premarket notification filed by Home Skinovations Ltd. with the FDA for Heatlux Pro Ii.
| Device ID | K152087 |
| 510k Number | K152087 |
| Device Name: | HeatLux Pro II |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-27 |
| Decision Date | 2016-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016627138 | K152087 | 000 |
| 17290015418901 | K152087 | 000 |
| 07290017992006 | K152087 | 000 |