B & L OPHTHALMIC CHAIR
FDA 510(k) clearance K791105 · decided 1979-07-24
Clearance details
- K-number
- K791105
- Device name
- B & L OPHTHALMIC CHAIR
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-06-13
- Decision date
- 1979-07-24
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- HMF
- Device class
- 1
- Regulation number
- 886.1860
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bausch & Lomb
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 |
|---|---|---|
| ROTA SYSTEM 5000 (K935952) | Rota Systems Medfurniture, Inc. | 1994-04-19 |
| ROTA DATAMATE I (K935945) | Rota Systems,Inc. | 1994-04-19 |
| ROTA SYSTEM XL (K931839) | Rota Systems Medfurniture, Inc. | 1993-11-22 |
| MARCO INTERNATIONAL STAND (K930440) | Marco Ophthalmic, Inc. | 1993-07-06 |
| BURTON OPHTHALMIC STAND - MODEL XL3200 (K924771) | R.H. Burton Co. | 1993-04-05 |
| BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 (K924780) | R.H. Burton Co. | 1993-04-05 |
| OPHTHALMIC STAND (K913961) | Luneau Ophtalmologie SA | 1991-12-04 |
| RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (K853358) | Dentsply Intl. | 1985-10-04 |
| OPHTHALMIC CHAIR (K844362) | Luneau Laboratories | 1984-12-11 |
| OPHTHALMIC STAND (K844363) | Luneau Laboratories | 1984-12-05 |
| ELECTRIC INSTRUMENT TABLE (K832073) | CooperVision, Inc. | 1983-08-12 |
| RELIANCE OPHTHALMIC INSTRUMENT CONTROL (K812544) | F. & F. Koenigkramer | 1981-09-21 |
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 |