BAUSCH & LOMB CONTACT LENS VIEWER
FDA 510(k) clearance K862517 · decided 1986-08-11
Clearance details
- K-number
- K862517
- Device name
- BAUSCH & LOMB CONTACT LENS VIEWER
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-01
- Decision date
- 1986-08-11
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- HLF
- Device class
- 1
- Regulation number
- 886.1430
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rochester, NY, 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 STANDARD RADIUSGAUGES (K930437) | Marco Ophthalmic, Inc. | 1993-08-09 |
| ERG-JET ELECTRODE (K823767) | Life-Tech Intl., Inc. | 1983-01-08 |
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 |