TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER
FDA 510(k) clearance K903421 · decided 1990-12-18
Clearance details
- K-number
- K903421
- Device name
- TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER
- Applicant
- Top Con
- Decision
- Substantially Equivalent
- Date received
- 1990-07-31
- Decision date
- 1990-12-18
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- HQF
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Paramus, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.