TBD KERATOSCOPE
FDA 510(k) clearance K912130 · decided 1991-08-09
Clearance details
- K-number
- K912130
- Device name
- TBD KERATOSCOPE
- Applicant
- Alcon Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1991-05-14
- Decision date
- 1991-08-09
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- HLQ
- Device class
- 1
- Regulation number
- 886.1350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alcon Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OPD-SCAN, MODELS ARK-10000 AND ARK-9000 (K003299) | Nidek Co., Ltd. | 2001-03-09 |
| EYE SYS VISTA (K973756) | Eyesys Technologies, Inc. | 1997-11-13 |
| EYECHEK (K964290) | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 1997-01-09 |
| TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (K945382) | Expertech Assoc., Inc. | 1995-01-31 |
| TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 (K944207) | Computed Anatomy, Inc. | 1994-12-07 |
| KERATRON CORNEAL TOPOGRAPHER (K944616) | Alliance Medical Marketinig | 1994-11-22 |
| ORBSCAN(TM) KERATOMETER (K940647) | Orbtek, Inc. | 1994-07-06 |
| EH-270 CORNEAL TOPOGRAPHER (K933556) | Visioptic, Inc. | 1993-11-02 |
| CORNEAL TOPOGRAPHY SYSTEM (K923435) | Par Microsystems Corp. | 1993-02-16 |
| KERATOREF L60 (K922253) | Luneau Ophtalmologie SA | 1992-06-19 |
| ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (K912740) | Visionary Systems, Inc. | 1991-12-30 |
| CCI VIDEOKERATOSCOPE/COMPARATOR (K913022) | Cci | 1991-10-09 |
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 |