HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
FDA 510(k) clearance K020527 · decided 2002-07-09
Clearance details
- K-number
- K020527
- Device name
- HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
- Applicant
- American Optisurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-19
- Decision date
- 2002-07-09
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic recall (Z-1808-2009) | American Optisurgical Inc | 2009-09-04 |