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510(k) Data Aggregation
K Number
K231838Device Name
RxSight® Insertion Device (63002)
Manufacturer
RxSight, Inc.
Date Cleared
2023-08-15
(54 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
RxSight, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RxSight® Insertion Device (Model 63002) is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device (Model 63002) is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, and IOL models validated for use with this device in IOL approved labeling.
Device Description
The RxSight Insertion Device (Model 63002) is a sterile, single-use device to be used to fold and insert intraocular lenses (IOL) into the eye through a small incision during cataract surgery. The RxSight Insertion Device (Model 63002) consists of:
- A single-use, disposable, sterile IOL inserter with a non-pyrogenic cartridge
- A single-use, disposable, sterile haptic puller.
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K Number
K231466Device Name
RxSight Insertion Device
Manufacturer
RxSight, Inc.
Date Cleared
2023-06-12
(24 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
RxSight, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RxSight® Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens®, RxSight Light Adjustable Lens+, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
Device Description
The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.
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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?
Applicant Name (Manufacturer) :
RxSight, Inc.
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.
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K Number
K192926Device Name
RxSight Insertion Device
Manufacturer
RxSight, Inc.
Date Cleared
2020-01-17
(93 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
RxSight, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is intended for the insertion of the RxSight Light Adjustable Lens, the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
Device Description
The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.
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K Number
K181401Device Name
RxSight Insertion Device
Manufacturer
RxSight, Inc.
Date Cleared
2018-07-26
(58 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
RxSight, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RxSight Insertion Device is indicated for the folding and insertion of a 3-piece silicone, intraocular lens into the human eye through a surgical incision. The RxSight Insertion Device is only for the Bausch & Lomb LI61A0 IOL and IOL models validated for use with this device in IOL approved labeling.
Device Description
The RxSight Insertion Device is a two-part IOL injector device comprised of a re-usable handheld titanium injector, and a single use, non-preloaded disposable polypropylene cartridge intended to be used to fold and insert the intraocular lenses into the eye through a small incision.
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