Heatlux
510(k) K120582
Heatlux 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) K120582 on 6 Jul 2012, 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 | NumberK120582 | Date6 Jul 2012 | StatusActive |
Official records
- FDA 510(k) database K120582
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- Withdrawn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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