MOLTENO3
FDA 510(k) clearance K062252 · decided 2006-09-27
Clearance details
- K-number
- K062252
- Device name
- MOLTENO3
- Applicant
- Iop, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-03
- Decision date
- 2006-09-27
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- KYF
- Device class
- 2
- Regulation number
- 886.3920
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Costa Mesa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.