NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
FDA 510(k) clearance K110228 · decided 2011-02-23
Clearance details
- K-number
- K110228
- Device name
- NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
- Applicant
- Nidek Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2011-01-26
- Decision date
- 2011-02-23
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- HQB
- Device class
- 2
- Regulation number
- 886.4690
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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