ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
FDA 510(k) clearance K912581 · decided 1991-12-23
Clearance details
- K-number
- K912581
- Device name
- ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
- Applicant
- Carl Zeiss, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-12
- Decision date
- 1991-12-23
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- HLI
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Princeton, NJ, 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 |
|---|---|---|
| RTVue XR OCT Avanti with AngioVue Software (K153080) | Optovue, Inc. | 2016-02-11 |
| EnFocus 2300, EnFocus 4400 (K150722) | Bioptigen, Inc. | 2015-12-02 |
| OCT-Camera (K142953) | Optomedical Technologies GmbH | 2015-03-04 |
| PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (K141638) | Propper Manufacturing Co., Inc. | 2014-09-17 |
| CENTERVUE MACULAR INTEGRITY ASSESSMENT (K133758) | Centervue S.P.A. | 2014-04-23 |
| AMICO DH-W35 OPHTHALMOSCOPE SERIES (K131939) | Amico Diagnostic Incorporated | 2014-03-26 |
| IVUE 500 (K133892) | Optovue, Inc. | 2014-03-19 |
| HEINE OMEGA 500 (K123316) | Heine Optotechnik GmbH & Co. KG | 2013-02-26 |
| IVUE WITH NORMATIVE DATABASE (K121739) | Optovue, Inc. | 2013-01-18 |
| ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (K120057) | Bioptigen, Inc. | 2012-05-11 |
| RTVUE XR OCT (K120238) | Optovue, Inc. | 2012-04-03 |
| RHA2020 (K111531) | Annidis Health Systems Corp. | 2011-07-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISULAS ND:YAG LASER (P850083/S008) | Carl Zeiss, Inc. | 1989-08-02 |
| VISULAS ND:YAG LASER (P850083/S007) | Carl Zeiss, Inc. | 1988-07-15 |
| VISULAS ND:YAG LASER (P850083/S006) | Carl Zeiss, Inc. | 1987-10-05 |
| VISULAS ND:YAG LASER (P850083/S005) | Carl Zeiss, Inc. | 1987-09-30 |
| VISULAS ND:YAG LASER (P850083/S004) | Carl Zeiss, Inc. | 1987-03-31 |
| VISULAS ND:YAG LASER (P850083/S001) | Carl Zeiss, Inc. | 1987-03-10 |
| VISULAS ND:YAG LASER (P850083/S003) | Carl Zeiss, Inc. | 1986-12-04 |