DIOPTRON III AUTOREFRACTOR
FDA 510(k) clearance K801906 · decided 1980-08-27
Clearance details
- K-number
- K801906
- Device name
- DIOPTRON III AUTOREFRACTOR
- Applicant
- Coherent Medical Division
- Decision
- Substantially Equivalent
- Date received
- 1980-08-11
- Decision date
- 1980-08-27
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- HKO
- Device class
- 1
- Regulation number
- 886.1760
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (K031831) | Topcon Medical Systems, Inc. | 2003-12-19 |
| WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 (K000327) | Visx, Incorporated | 2000-05-02 |
| DIGITAL RETINOSCOPIC PHOTOMETER (K951179) | Kudi Kalu, Inc. | 1995-05-30 |
| VIDEO VISION ANALYZER (VIVA), VRB 100 (K945959) | Tomey Corporation USA | 1995-03-01 |
| AUTO REF-KERATOMETER, RK-3 (K942242) | Cannon U.S.A., Inc. | 1994-09-02 |
| AUTO REFF-30 (K940516) | Canon, Inc. | 1994-07-12 |
| AUTOREF LENSMETER RL-10 (K925304) | Canon USA, Inc. | 1994-02-17 |
| OPTEC 3000 (K924741) | Stereo Optical Co., Inc. | 1993-04-06 |
| BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 (K924778) | R.H. Burton Co. | 1993-04-05 |
| BURTON AUTO REFRACTOR - MODEL BAR-7 (K924790) | R.H. Burton Co. | 1993-04-05 |
| OPTEC 2300 AFVT, ARMED FORCES VISION TESTER (K904828) | Stereo Optical Co., Inc. | 1991-01-18 |
| AR-1600G AUTO-REFRACTOMETER (K902500) | Nidek, Inc. | 1990-07-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S022) | Coherent Medical Division | 1989-08-29 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S021) | Coherent Medical Division | 1988-08-30 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S020) | Coherent Medical Division | 1987-12-01 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S019) | Coherent Medical Division | 1987-07-21 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S018) | Coherent Medical Division | 1987-05-19 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S017) | Coherent Medical Division | 1987-03-31 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S015) | Coherent Medical Division | 1986-12-01 |
| NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S009) | Coherent Medical Division | 1986-11-07 |