THL1 LASER
FDA 510(k) clearance K100509 · decided 2010-06-08
Clearance details
- K-number
- K100509
- Device name
- THL1 LASER
- Applicant
- Erchonia Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-02-22
- Decision date
- 2010-06-08
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- NHN
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Littleton, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.