Search Results
Found 14 results
510(k) Data Aggregation
K Number
K201909Device Name
RxSight Contact Lens
Manufacturer
RxSight, Inc.
Date Cleared
2020-09-10
(63 days)
Product Code
HJK
Regulation Number
886.1385Why did this record match?
Product Code :
HJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RxSight Contact Lens is indication and treatment in the anterior segment of the eye.
Device Description
The RxSight Contact Lens is a reusable diagnostic contact lens intended for intraocular visualization and therapy. The RxSight Contact Lens is used to maintain optical quality of the corneal surface and will provide lid stabilization to prevent blinking during therapeutic procedures that require magnification of the eye.
The RxSight Contact Lens is designed around the classic diagnostic contact lens with similar design including an optical element with a specific magnification to provide excellent visualization.
The optical component of the RxSight Contact Lens is made from polymethylmethacrylate (PMMA). The anodized aluminum cone houses the PMMA contact lens.
Ask a Question
K Number
K173944Device Name
Endocular Viewing Lenses and Silicone Ring
Manufacturer
Phakos
Date Cleared
2018-10-25
(303 days)
Product Code
HJK
Regulation Number
886.1385Why did this record match?
Product Code :
HJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizations of the retina, the vireous humor, the lens, the iris, the anterior chamber, as well as other ocular structures during surgical procedures or consultation.
The endocular viewing lens is a passive device that is used to view the fundus of the eye by placing it on the cornea.
Device Description
The "ENDOCULAR VIEWING LENSES AND SILICONE RING" family includes devices comprised of an endocular viewing lens and/or of a cornea support that allows for stabilization of this lens on the eye. This range allows one to view the retina, the vitreous humor, the lens, the iris, the angle of the anterior chamber, as well as other ocular structures during surgical procedures or consultation.
Ask a Question
K Number
K151961Device Name
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
Manufacturer
Volk Optical Inc.
Date Cleared
2015-08-18
(33 days)
Product Code
HJK
Regulation Number
886.1385Why did this record match?
Product Code :
HJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.
Device Description
The Volk Disposable Contact Laser and Diagnostic Lenses are a family of diagnostic and therapeutic contact lenses used for eye fundus examinations and therapy of intraocular abnormalities. The family consists of two (2) lenses, including the following: Iridotomy Lens and Capsulotomy Lens.
The family of Volk Disposable Contact Laser and Diagnostic Lenses are designed around the classic Volk Contact Laser and Diagnostic Lenses. Each model lens is similar in design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use.
The lenses are provided sterile for single use.
Ask a Question
K Number
K142715Device Name
Sensor Medical Family of Vitrectomy Lenses and Products
Manufacturer
Sensor Medical Technology, LLC
Date Cleared
2014-12-16
(85 days)
Product Code
HJK, HNR
Regulation Number
886.1385Why did this record match?
Product Code :
HJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sensor Medical Family of Vitrectomy Lenses and Products allows visualization of the ocular fundus, vitreous and retinal structures during vitrectomy surgery.
Device Description
The Sensor Medical Family of Vitrectomy Lenses and Products includes single-use, disposable, sterile devices for use during vitrectomy surgery. The following devices are included in the family: Plano Lens, Magnifier Lens, Bi-Concave Lens, 20 degree Prism Lens, 30 degree Prism Lens, Osher 78 D Lens, Suture Ring, Silicone Ring, and Lens Forceps.
The Sensor Medical Family of Vitrectomy Lenses and Products is designed around the classic Goldmann contact lens. Each style of lens is of similar design, with slight variations in the posterior surface shape to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with an operating microscope, the ophthalmic lenses provide a binocular and stereoscopic view of the specific optical region of the eye.
The lenses typically consist of a PMMA (acrylic) optical element that is applied for a short period of time directly on the globe or cornea of the eye.
Ask a Question
K Number
K051630Device Name
SUPER VIEW DISPOSABLE BIOM LENS SET
Manufacturer
INSIGHT INSTRUMENTS, INC.
Date Cleared
2005-06-29
(12 days)
Product Code
HJK
Regulation Number
886.1385Why did this record match?
Product Code :
HJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.
Device Description
The Super View Disposable BIOM Lens Set(s) consists of multiple sterile, disposable, thermoplastic lenses for both contact and non-contact use in conjunction with an operating microscope equipped with a BIOM wide-angle viewing system.
Ask a Question
K Number
K051103Device Name
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
Manufacturer
HAAG-STREIT USA, INC.
Date Cleared
2005-06-07
(39 days)
Product Code
HJK
Regulation Number
886.1385Why did this record match?
Product Code :
HJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Haag-Streit Contact Glasses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and irido-corneal angle, and for the laser therapy of intraocular abnormalities.
Device Description
The HS Contact Glasses is a family of diagnostic and therapeutic contact lenses used for eye examination and therapy of intraocular abnormalities. The HS Contact Glass family is designed around the classic Goldmann contact lenses. All HS Contact Glass models are of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with the HS 900 slit-lamp, the HS Contact Glasses provide a binocular and stereoscopic view of the specific optical region of the eye. The HS Contact Glass typically consists of an aluminum housing, one or more mirror elements and a carved of time directly on the globe or cornea of the eye. The HS contact glass family has two principal modes of use. Those used with laser radiation for therapy of ocular abnormalities. HS Contact Glasses used in diagnostic procedures are made of acrylic plastic (PMMA). These are doolgnou with slit-lamps, such as fundus, the vitreous and the may of HS diagnostic Contact Glasses have the Flaag Otreit Bookine by Goldmann: 59/ 66/ 73 degrees.
Ask a Question
K Number
K050623Device Name
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
Manufacturer
VOLK OPTICAL, INC.
Date Cleared
2005-03-28
(18 days)
Product Code
HJK
Regulation Number
886.1385Why did this record match?
Product Code :
HJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.
Device Description
The subject device is a diagnostic and therapeutic contact lens system used for eye fundus examination and therapy of intraocular abnormalities. The lens is one element made from PMMA (polymethylmethracryalate). The lens is a sterile, disposable, single use device.
Ask a Question
K Number
K033950Device Name
DORC VITRECTOMY LENSES, MODEL 1284 SERIES
Manufacturer
DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.)
Date Cleared
2004-02-20
(60 days)
Product Code
HJK
Regulation Number
886.1385Why did this record match?
Product Code :
HJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vitrectomy Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Vitrectomy lenses are indicated for use during vitreoretinal surgical procedures.
Device Description
D.O.R.C. Vitrectomy Lens includes a variety of designs both sterile, single use, disposable vitrectomy lenses, as well as vitrectomy lenses intended to be reused which are sold non-sterile.
Ask a Question
K Number
K030054Device Name
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
2003-02-26
(51 days)
Product Code
HJK, HMX, HNN
Regulation Number
886.1385Why did this record match?
Product Code :
HJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable Vitrectorny Set is used in the context of vitrectorny procedures. The self-blocking infusion cannula with infusion tubing provides the saline solution or balanced saline solution throughout the procedure, ensuring that the eye retains its tonicity. No sutures are required. The knife is used for making a calibrated and non-leaking incision into which the self-blocking infusion cannula is inserted. The lens, used with microscope, facilitates visualization of the retina by canceling the corneal diopter. An edge, which has a frosted ring on its upper side to avoid edge glare effects, allows users to position and move the lens on the cornea with forceps.
Device Description
Not Found
Ask a Question
K Number
K023221Device Name
CONTACT LASER & DIAGNOSTIC LENSES
Manufacturer
VOLK OPTICAL, INC.
Date Cleared
2002-10-11
(14 days)
Product Code
HJK
Regulation Number
886.1385Why did this record match?
Product Code :
HJK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for use as a diagnostic contact lens for eye fundus examinations and use in the therapy of intraocular abnormalities.
Device Description
Not Found
Ask a Question
Page 1 of 2