510(k) K151961
- Device
- Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
- Applicant
- Volk Optical Inc.
- 510(k) number
- K151961
- Product code
- HJK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-08-18
- Date received
- 2015-07-16
- Regulation
- 886.1385
- Classification name
- Lens, Contact, Polymethylmethacrylate, Diagnostic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Meghan M Leonard
- Address
- 7893 Enterprise Dr. Mentor OH US 44060 44060
FDA Registration Numbers#
- 1058584
- 3014865
- 3012375451
- 2027619
- 3035451914
- 3009773841
- 9611516
- 2242450
- 1000176188
- 1225798
- 9615745
- 3004467263
- 1054811
- 2030624
- 3004207966
- 3005941719
- 3004519921
- 1000286794
- 3015177648
- 3002991496
- 2939653
- 3009337401
- 3006142778
- 1528142
- 3013002167
- 2183744
- 3012712027
Source Documents#
Other 510(k) Records For Product Code HJK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201909 | RxSight Contact Lens | Rxsight, Inc. | 2020-09-10 |
| K173944 | Endocular Viewing Lenses and Silicone Ring | Phakos | 2018-10-25 |
| K142715 | Sensor Medical Family of Vitrectomy Lenses and Products | Sensor Medical Technology, LLC | 2014-12-16 |
| K051630 | SUPER VIEW DISPOSABLE BIOM LENS SET | Insight Instruments, Inc. | 2005-06-29 |
| K051103 | HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY | Haag-Streit USA, Inc. | 2005-06-07 |
| K050623 | VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D | Volk Optical, Inc. | 2005-03-28 |
| K033950 | DORC VITRECTOMY LENSES, MODEL 1284 SERIES | Dutch Ophthalmic Research Center (D.O.R.C.) | 2004-02-20 |
| K030054 | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES | Fci Ophthalmics, Inc. | 2003-02-26 |
| K023221 | CONTACT LASER & DIAGNOSTIC LENSES | Volk Optical, Inc. | 2002-10-11 |
| K022413 | LUNEAU 3 MIRROR LENS | Luneau SA | 2002-09-24 |
| K014170 | STAURENGHI WIDE FIELD SCANNING LASER LENS | Ocular Instruments, Inc. | 2002-03-04 |
| K012096 | DISPOSABLE VITRECTOMY LENS | Ocular Instruments, Inc. | 2001-08-24 |
| K971853 | ENDOVIEW SPPHIRE LENS SET | American Medical Devices, Inc. | 1997-08-06 |
| K933976 | MANDELKORN SUTURE LYSIS LENS | Ocular Instruments, Inc. | 1994-11-08 |
| K933264 | RITCH NYLON SUTURE LASER LENS | Ocular Instruments, Inc. | 1994-10-31 |
Legacy Summary#
summary
FDA Review#
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