METRO SOFT
FDA 510(k) clearance K100244 · decided 2010-10-28
Clearance details
- K-number
- K100244
- Device name
- METRO SOFT
- Applicant
- Metro Optics of Austin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-01-27
- Decision date
- 2010-10-28
- Days to decision
- 274 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Grand Junction, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.