KARICKHOFF DIAGNOSTIC/LASER LENS
FDA 510(k) clearance K862692 · decided 1986-08-21
Clearance details
- K-number
- K862692
- Device name
- KARICKHOFF DIAGNOSTIC/LASER LENS
- Applicant
- Ocular Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-15
- Decision date
- 1986-08-21
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- HKS
- Device class
- 1
- Regulation number
- 886.1660
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Bellevue, WA, 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 |
|---|---|---|
| FAMILY OF DISPOSABLE LENSES (K140368) | Sensor Medical Technology, LLC | 2014-04-29 |
| OSHER SURGICAL GONIO/POSTERIOR POLE LENS (K935302) | Ocular Instruments, Inc. | 1994-04-01 |
| TWO MIRROR GONIO LENS (K895846) | Ocular Instruments, Inc. | 1989-12-18 |
| MCINTYRE SURGICAL GONIOLENS (K890977) | Ocular Instruments, Inc. | 1989-05-23 |
| ABRAHAM IRIDECTOMY LENS (YAG LASER) (K862713) | Ocular Instruments, Inc. | 1986-08-21 |
| RITCH TRABECULOPLASTY LASER LENS (K862512) | Ocular Instruments, Inc. | 1986-07-11 |
| SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM (K862024) | Ocular Instruments, Inc. | 1986-07-11 |
| KETA HAND-HELD TONOMETER (K861027) | Keta Corp. | 1986-05-06 |
| DORC ADJUSTABLE IMAGE CONTACTS (K830169) | Jedmed Instrument Co. | 1983-02-07 |
Recalls involving this device
No recalls on record reference this clearance.