CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
FDA 510(k) clearance K000637 · decided 2000-05-19
Clearance details
- K-number
- K000637
- Device name
- CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
- Applicant
- Alcon Laboratories, Inc.
- Decision
- Unknown
- Date received
- 2000-02-25
- Decision date
- 2000-05-19
- Days to decision
- 84 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K062930) | Alcon Research, Ltd. | 2006-11-08 |
| OPD-STATION SOFTWARE (K050336) | Nidek, Inc. | 2005-08-24 |
| ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K023249) | Alcon Laboratories, Inc. | 2002-10-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S159) | Alcon Laboratories, Inc. | 2025-12-12 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S158) | Alcon Laboratories, Inc. | 2025-09-18 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S157) | Alcon Laboratories, Inc. | 2025-08-25 |
| AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (P930014/S152) | Alcon Laboratories, Inc. | 2025-06-18 |
| AcrySof Posterior Chamber Intraocular Lenses (P930014/S154) | Alcon Laboratories, Inc. | 2025-03-21 |
| WaveLight EX500 Laser (P020050/S043) | Alcon Laboratories, Inc. | 2025-03-05 |
| AcrySof Posterior Chamber Intraocular Lens (IOL) (P930014/S155) | Alcon Laboratories, Inc. | 2025-02-14 |
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S153) | Alcon Laboratories, Inc. | 2025-02-04 |