OptonPro 4682
OptonPro 4682 is a musculoskeletal/physical therapy laser (FDA Class II; FDA product code ILY, Lamp, Infrared, Therapeutic Heating) made by Zimmer MedizinSysteme GmbH, cleared under FDA 510(k) K141564 on 24 Oct 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04053815053972), 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 | GUDID listing | Number04053815053972 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141564 | Date24 Oct 2014 | StatusActive |
Official records
- AccessGUDID record 04053815053972
- FDA 510(k) database K141564
Across registries
- FDA 510(k) K141564 decided 24 Oct 2014 Active
- FDA GUDID UDI-DI 04053815053972 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K141564
- Listed FDA GUDID 04053815053972
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OptonPro
- Generic name
- Musculoskeletal/physical therapy laser, professional
- Model / Ref / Catalog
- 4682
- Primary DI / UDI-DI
- 04053815053972
- 510(k) Number
- FDA product code
- ILY
- GMDN term
- Musculoskeletal/physical therapy laser, professional
- Device class
- Class II
- Regulation number
- 890.5500
- GUDID distribution status
- In Commercial Distribution
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