VIEWPOINT CK SYSTEM
FDA premarket approval P010018/S004 · decided 2003-07-31
Approval details
- PMA number
- P010018
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- VIEWPOINT CK SYSTEM
- Generic name
- Electrosurgical, radio frequency, refractive correction
- Applicant
- Refractec, Inc.
- Date received
- 2003-07-16
- Decision date
- 2003-07-31
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- MWD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE SUB-ASSEMBLY OF THE RCS-300 CONSOLE. THE MANUFACTURING FACILITY IS LOCATED AT REFRACTEC, INC., IRVINE, CALIFORNIA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 (K053475) | Refractec, Inc. | 2006-03-03 |
| REFRACTEC MCS-100 (K980522) | Refractec, Inc. | 1998-07-22 |