Laser Applicator 2401
Laser Applicator 2401 is a Class II device made by Mettler Electronics Corp., cleared under FDA 510(k) K113017 on 26 Jun 2012 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 00816864020579), active as of 8 Jun 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 | Number00816864020579 | Date15 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113017 | Date26 Jun 2012 | StatusActive |
Official records
- AccessGUDID record 00816864020579
- FDA 510(k) database K113017
Across registries
- FDA 510(k) K113017 decided 26 Jun 2012 Active
- FDA GUDID UDI-DI 00816864020579 listed 15 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K113017
- Listed FDA GUDID 00816864020579
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Physical therapy transcutaneous electrical stimulation system, line-powered
- Model / Ref / Catalog
- 2401
- Primary DI / UDI-DI
- 00816864020579
- 510(k) Number
- FDA product code
- IPF, LIH, ILY, GZJ
- GMDN term
- Physical therapy transcutaneous electrical stimulation system, line-powered
- Device class
- Class II
- Regulation number
- 890.5850, 882.5890, 890.5500
- GUDID distribution status
- In Commercial Distribution
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