RXSIGHT, INC.

Address:100 Columbia,Aliso Viejo,CA,92656,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) (PZK) (9) Folders And Injectors, Intraocular Lens (Iol) (MSS) (1)

Premarket Exempt

No Yes

Clear

RxSight Injector Handpiece - 00818806020005 Catalog Number :

Device Description : Injector Handpiece

Device Class : 1

Duns Number: 052054413

Premarket Exempt : No

Product Code : MSS

Prescription Use : Yes

Device Count : 1

RxSight Light Delivery Device (LDD) - 00818806020029 Catalog Number :

Device Description : Light Delivery Device

Device Class : 3

Duns Number: 052054413

Premarket Exempt : No

Product Code : PZK

Prescription Use : No

Device Count : 1

RxSight Light Adjustable Lens (RxLAL) - 00818806020036 Catalog Number :

Device Description : LAL, Sterile, Packaged, 10.0 Diopter

Device Class : 3

Duns Number: 052054413

Premarket Exempt : No

Product Code : PZK

Prescription Use : Yes

Device Count : 1

RxSight Light Adjustable Lens (RxLAL) - 00818806020043 Catalog Number :

Device Description : LAL, Sterile, Packaged, 11.0 Diopter

Device Class : 3

Duns Number: 052054413

Premarket Exempt : No

Product Code : PZK

Prescription Use : Yes

Device Count : 1

RxSight Light Adjustable Lens (RxLAL) - 00818806020050 Catalog Number :

Device Description : LAL, Sterile, Packaged, 12.0 Diopter

Device Class : 3

Duns Number: 052054413

Premarket Exempt : No

Product Code : PZK

Prescription Use : Yes

Device Count : 1

RxSight Light Adjustable Lens (RxLAL) - 00818806020067 Catalog Number :

Device Description : LAL, Sterile, Packaged, 13.0 Diopter

Device Class : 3

Duns Number: 052054413

Premarket Exempt : No

Product Code : PZK

Prescription Use : Yes

Device Count : 1

RxSight Light Adjustable Lens (RxLAL) - 00818806020074 Catalog Number :

Device Description : LAL, Sterile, Packaged, 14.0 Diopter

Device Class : 3

Duns Number: 052054413

Premarket Exempt : No

Product Code : PZK

Prescription Use : Yes

Device Count : 1

RxSight Light Adjustable Lens (RxLAL) - 00818806020081 Catalog Number :

Device Description : LAL, Sterile, Packaged, 15.0 Diopter

Device Class : 3

Duns Number: 052054413

Premarket Exempt : No

Product Code : PZK

Prescription Use : Yes

Device Count : 1

RxSight Light Adjustable Lens (RxLAL) - 00818806020098 Catalog Number :

Device Description : LAL, Sterile, Packaged, 16.0 Diopter

Device Class : 3

Duns Number: 052054413

Premarket Exempt : No

Product Code : PZK

Prescription Use : Yes

Device Count : 1

RxSight Light Adjustable Lens (RxLAL) - 00818806020104 Catalog Number :

Device Description : LAL, Sterile, Packaged, 16.5 Diopter

Device Class : 3

Duns Number: 052054413

Premarket Exempt : No

Product Code : PZK

Prescription Use : Yes

Device Count : 1

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