PALLIKARIS BRUSH
FDA 510(k) clearance K960261 · decided 1996-03-11
Clearance details
- K-number
- K960261
- Device name
- PALLIKARIS BRUSH
- Applicant
- Alcon Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-18
- Decision date
- 1996-03-11
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- HOG
- Device class
- 1
- Regulation number
- 886.4070
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Orlando, FL, 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 |
|---|---|---|
| AMOILS EPITHELIAL SCRUBBER (K962989) | S. Percy Amoils | 1997-01-09 |
| BURR, CORNEAL, BATTERY-POWERED (K950520) | Aaron Medical Industries | 1995-05-02 |
| GY-RO SAFE (K883785) | Gy-Ro Industry, Inc. | 1989-01-05 |
| OPHTEC RUST RING REMOVER (K834354) | Jedmed Instrument Co. | 1984-03-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S159) | Alcon Laboratories, Inc. | 2025-12-12 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S158) | Alcon Laboratories, Inc. | 2025-09-18 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S157) | Alcon Laboratories, Inc. | 2025-08-25 |
| AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (P930014/S152) | Alcon Laboratories, Inc. | 2025-06-18 |
| AcrySof Posterior Chamber Intraocular Lenses (P930014/S154) | Alcon Laboratories, Inc. | 2025-03-21 |
| WaveLight EX500 Laser (P020050/S043) | Alcon Laboratories, Inc. | 2025-03-05 |
| AcrySof Posterior Chamber Intraocular Lens (IOL) (P930014/S155) | Alcon Laboratories, Inc. | 2025-02-14 |
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S153) | Alcon Laboratories, Inc. | 2025-02-04 |