ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
FDA 510(k) clearance K012435 · decided 2001-10-02
Clearance details
- K-number
- K012435
- Device name
- ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-31
- Decision date
- 2001-10-02
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- NGY
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
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| Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S036) | Bausch & Lomb, Inc. | 2025-07-22 |
| Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S035) | Bausch & Lomb, Inc. | 2025-07-09 |
| enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S060) | Bausch & Lomb, Inc. | 2025-06-18 |
| enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S059) | Bausch & Lomb, Inc. | 2025-05-30 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S004) | Bausch & Lomb, Inc. | 2025-05-30 |