LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
FDA 510(k) clearance K062930 · decided 2006-11-08
Clearance details
- K-number
- K062930
- Device name
- LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
- Applicant
- Alcon Research, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-28
- Decision date
- 2006-11-08
- Days to decision
- 41 days
- Clearance type
- Abbreviated
- Product code
- NCF
- Device class
- 1
- Regulation number
- 886.1760
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Orlando, FL, 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 |
|---|---|---|
| OPD-STATION SOFTWARE (K050336) | Nidek, Inc. | 2005-08-24 |
| ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K023249) | Alcon Laboratories, Inc. | 2002-10-18 |
| CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) (K000637) | Alcon Laboratories, Inc. | 2000-05-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S117) | Alcon Research, Ltd. | 2025-12-12 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S069) | Alcon Research, Ltd. | 2025-10-03 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S116) | Alcon Research, Ltd. | 2025-09-18 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses\s (P040020/S115) | Alcon Research, Ltd. | 2025-08-25 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S068) | Alcon Research, Ltd. | 2025-07-25 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S111) | Alcon Research, Ltd. | 2025-06-18 |
| PROVSIC Ophthalmic Viscosurgical Device (P890047/S067) | Alcon Research, Ltd. | 2025-02-26 |
| AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL) (P040020/S113) | Alcon Research, Ltd. | 2025-02-14 |