ALCON OPERATING MICROSCOPES
FDA 510(k) clearance K920641 · decided 1992-10-09
Clearance details
- K-number
- K920641
- Device name
- ALCON OPERATING MICROSCOPES
- Applicant
- Alcon Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1992-02-12
- Decision date
- 1992-10-09
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- HRM
- Device class
- 1
- Regulation number
- 878.4700
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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 |
|---|---|---|
| HM-0970 (K932720) | Hill-Med, Inc. | 1993-09-07 |
| MARCO SURGISCOPE OPERATION MICROSCOPES (K930439) | Marco Ophthalmic, Inc. | 1993-07-22 |
| KEELER KONAN SPECULAR MICROSCOPE SP5500 (K914956) | Keeler Instruments, Inc. | 1992-02-03 |
| S 22 INSTRUMENT STAND (K891584) | Carl Zeiss, Inc. | 1989-06-08 |
| MICROSCOPE KNOB COVER, STERILE, DISPOSABLE (K891001) | Prescott'S, Inc. | 1989-04-11 |
| MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 (K854440) | Keeler Instruments, Inc. | 1985-12-16 |
| XTAL X-150 OPERATING MICROSCOPE (K853855) | Xtal Corp. | 1985-10-15 |
| CROMIC SURGICAL MICROSCOPE MODEL MC-1 (K852586) | Seltrex, Corp. | 1985-07-30 |
| CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 (K852150) | Keeler Instruments, Inc. | 1985-06-03 |
| CORNEAL LIGHT SHIELD (K850270) | Mentor O & O, Inc. | 1985-05-31 |
| KONAN CLINIC MICROSCOPE CLM-100-150 (K844323) | Keeler Instruments, Inc. | 1984-11-21 |
| OPHTHALMIC MICROSCOPE (K822563) | Treace Medical, Inc. | 1982-09-14 |
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 |