CHIROFLEX II LENS MICROSERT(TM)
FDA 510(k) clearance K914311 · decided 1992-01-27
Clearance details
- K-number
- K914311
- Device name
- CHIROFLEX II LENS MICROSERT(TM)
- Applicant
- Chiron Ophthalmics
- Decision
- Substantially Equivalent
- Date received
- 1991-09-26
- Decision date
- 1992-01-27
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- HQL
- Device class
- 3
- Regulation number
- 886.3600
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, 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 |
|---|---|---|
| SOFTRANS INJECTOR (K913626) | Staar Surgical Co. | 1991-12-18 |
| NIDEK DIGITAL KERATOMETER (K842892) | Nidek, Inc. | 1984-10-05 |
| AMER. MEDICAL OPTICS DIGITAL KERATO- (K842504) | American Medical Optics | 1984-10-01 |
| CILCO ANTERIOR CHAMBER LENS (K771933) | California Intraocular Lens | 1978-01-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TIER A & B INTRAOCULAR LENSES (P890068/S001) | Chiron Ophthalmics | 1993-10-22 |
| MODEL P-11 MODIFIED J-LOOP POSTERIOR CHAMBER IOL (P890068) | Chiron Ophthalmics | 1990-01-11 |