HeatLux Pro I
510(k) K150175
HeatLux Pro I is a medical device (FDA Class II; FDA product code ILY, Lamp, Infrared, Therapeutic Heating) made by Home Skinovations, Ltd., cleared under FDA 510(k) K150175 on 31 Mar 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150175 | Date31 Mar 2015 | StatusActive |
Official records
- FDA 510(k) database K150175
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ILY
- FDA applicant
- Home Skinovations , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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