TBD, LENS MEASURING DEVICE
FDA 510(k) clearance K912134 · decided 1991-07-25
Clearance details
- K-number
- K912134
- Device name
- TBD, LENS MEASURING DEVICE
- Applicant
- Alcon Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1991-05-14
- Decision date
- 1991-07-25
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- HRJ
- Device class
- 1
- Regulation number
- 886.4855
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fort Worth, TX, 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 |
|---|---|---|
| MARCO H AND TS-1 INSTRUMENT TABLES (K930447) | Marco Ophthalmic, Inc. | 1993-07-06 |
| 910T MONTORIZED INSTRUMENT TABLE (K922242) | R.H. Burton Co. | 1992-09-30 |
| TECHNA VISION, INC.ELECTRIC TABLE (K853744) | Techna Vision | 1985-10-17 |
| RELIANCE 1379 (K853359) | Dentsply Intl. | 1985-09-24 |
| WOODLYN CLASSIC INSTRUMENT STAND (K841760) | Woodlyn, Inc. | 1984-06-19 |
| MACHEMER/TANO ROTATING (K833820) | Optical Micro Systems, Inc. | 1984-01-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System; DISCOVISC Ophthalmic Viscosurgical D (P840064/S091) | Alcon Laboratories | 2025-10-03 |
| VISCOAT Ophthalmic Viscosurgical Device, DISCOVISC Ophthalmic Viscosurgical Device (P840064/S090) | Alcon Laboratories | 2025-07-25 |
| DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088) | Alcon Laboratories | 2025-02-26 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086) | Alcon Laboratories | 2024-08-12 |
| PMMA Single-Piece Anterior Chamber IOL (P880087/S033) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051) | Alcon Laboratories | 2024-06-20 |
| PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071) | Alcon Laboratories | 2024-06-20 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System, DISCOVISC Ophthalmic Viscosurgical (P840064/S085) | Alcon Laboratories | 2024-06-17 |