FAMILY OF DISPOSABLE LENSES
FDA 510(k) clearance K140368 · decided 2014-04-29
Clearance details
- K-number
- K140368
- Device name
- FAMILY OF DISPOSABLE LENSES
- Applicant
- Sensor Medical Technology, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-02-14
- Decision date
- 2014-04-29
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- HKS
- Device class
- 1
- Regulation number
- 886.1660
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- North Reading, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sensor Medical Technology
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| 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 |
| KARICKHOFF DIAGNOSTIC/LASER LENS (K862692) | 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.