PROJECTOR, ACCU-CHART ACUITY
FDA 510(k) clearance K781658 · decided 1978-10-17
Clearance details
- K-number
- K781658
- Device name
- PROJECTOR, ACCU-CHART ACUITY
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-09-28
- Decision date
- 1978-10-17
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- HOS
- Device class
- 1
- Regulation number
- 886.1680
- 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 |
|---|---|---|
| WIRELESS CHART PROJECTOR,HCP-W 721 (K936200) | Canon USA, Inc. | 1994-09-28 |
| MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE (K930443) | Marco Ophthalmic, Inc. | 1993-07-06 |
| BURTON PROJECTOR HEAD - MODEL 6000-H (K924784) | R.H. Burton Co. | 1993-04-05 |
| OPHTHALMIC PROJECTOR (K921214) | Luneau Ophtalmologie SA | 1992-06-11 |
| WOODLYN OPHTHALMIC PROJECTOR (K890992) | Woodlyn, Inc. | 1989-05-17 |
| BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR (K862519) | Bausch & Lomb, Inc. | 1986-07-23 |
| MILLER/NADLER GLARE TESTER (K812706) | Mosebach Electric & Supply | 1981-11-16 |
| ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ (K811180) | American Optical Corp. | 1981-05-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Bausch & Lomb SofLens® (polymacon) Contact Lenses (N16895/S107) | Bausch & Lomb, Inc. | 2025-10-24 |
| Akreos Posterior Chamber Intraocular Lens (P060022/S037) | Bausch & Lomb, Inc. | 2025-09-30 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S003) | Bausch & Lomb, Inc. | 2025-07-30 |
| Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S036) | Bausch & Lomb, Inc. | 2025-07-22 |
| Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S035) | Bausch & Lomb, Inc. | 2025-07-09 |
| enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S060) | Bausch & Lomb, Inc. | 2025-06-18 |
| enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S059) | Bausch & Lomb, Inc. | 2025-05-30 |
| enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S004) | Bausch & Lomb, Inc. | 2025-05-30 |