ML830TP
by Microlight Corporation of America
510(k) K080786
ML830TP is a medical device (FDA Class II; FDA product code ILY, Lamp, Infrared, Therapeutic Heating) made by Microlight Corporation of America, cleared under FDA 510(k) K080786 on 3 Oct 2008, 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 | NumberK080786 | Date3 Oct 2008 | StatusActive |
Official records
- FDA 510(k) database K080786
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ILY
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5500
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K080786
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ML 830® ML-830-07-000 | ML-830-07-000 / ML-830-07-000 | 00859626006251 | — | On the market |
| ML 830® ML-830-07-002 | ML-830-07-002 / ML-830-07-002 | 00859626006275 | — | On the market |
| ML 830® ML-830-07-100 | ML-830-07-100 / ML-830-07-100 | 00859626006343 | — | On the market |
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