510(k) K140368
- Device
- FAMILY OF DISPOSABLE LENSES
- Applicant
- SENSOR MEDICAL TECHNOLOGY, LLC
- 510(k) number
- K140368
- Product code
- HKS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-04-29
- Date received
- 2014-02-14
- Regulation
- 886.1660
- Classification name
- Prism, Gonioscopic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MAUREEN O'CONNELL
- Address
- 5 Timber Ln. North Reading MA US 01864 01864
FDA Registration Numbers#
- 9611269
- 3014865
- 3004215117
- 1836161
- 3012375451
- 3012185136
- 3003951061
- 3035451914
- 1937310
- 3031231776
- 3009773841
- 2242450
- 1225798
- 2529846
- 3004207966
- 3015177648
- 1528142
- 2183744
- 1058726
Source Documents#
Other 510(k) Records For Product Code HKS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935302 | OSHER SURGICAL GONIO/POSTERIOR POLE LENS | Ocular Instruments, Inc. | 1994-04-01 |
| K895846 | TWO MIRROR GONIO LENS | Ocular Instruments, Inc. | 1989-12-18 |
| K890977 | MCINTYRE SURGICAL GONIOLENS | Ocular Instruments, Inc. | 1989-05-23 |
| K862692 | KARICKHOFF DIAGNOSTIC/LASER LENS | Ocular Instruments, Inc. | 1986-08-21 |
| K862713 | ABRAHAM IRIDECTOMY LENS (YAG LASER) | Ocular Instruments, Inc. | 1986-08-21 |
| K862024 | SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM | Ocular Instruments, Inc. | 1986-07-11 |
| K862512 | RITCH TRABECULOPLASTY LASER LENS | Ocular Instruments, Inc. | 1986-07-11 |
| K861027 | KETA HAND-HELD TONOMETER | Keta Corp. | 1986-05-06 |
| K830169 | DORC ADJUSTABLE IMAGE CONTACTS | Jedmed Instrument Co. | 1983-02-07 |
Legacy Summary#
summary
FDA Review#
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