ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)
FDA 510(k) clearance K013756 · decided 2002-08-29
Clearance details
- K-number
- K013756
- Device name
- ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)
- Applicant
- Argus Biomedical Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-13
- Decision date
- 2002-08-29
- Days to decision
- 289 days
- Clearance type
- Traditional
- Product code
- HQM
- Device class
- 2
- Regulation number
- 886.3400
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Boston Keratoprosthesis, Type I Lucia (K182986) | Massachusetts Eye and Ear Infirmary D/B/A Boston | 2019-01-30 |
| BOSTON KERATOPROSTHESIS OR BOSTON KPRO (K121203) | Massachusetts Eye & Ear Infirmary | 2013-05-10 |
| DOHLMAN DOANE KERATOPROTHESIS (K915062) | Mackeen Consultants, Ltd. | 1992-01-21 |
Recalls involving this device
No recalls on record reference this clearance.