RXSIGHT, INC.

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

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Filters

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

Sunglasses (Non-Prescription Including Photosensitive) (HQY) (9) Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) (PZK) (1)

Premarket Exempt

No Yes

Clear

RxSight Light Adjustable Lens (RxLAL) - 00818806020319 Catalog Number :

Device Description : LAL, Sterile, Packaged, 30.0 Diopter

Device Class : 3

Duns Number: 052054413

Premarket Exempt : No

Product Code : PZK

Prescription Use : Yes

Device Count : 1

RxLAL Post Op Spectacles - 00818806020326 Catalog Number :

Device Description : Post Op Spectacles

Device Class : 1

Duns Number: 052054413

Premarket Exempt : Yes

Product Code : HQY

Prescription Use : No

Device Count : 1

Post Op Spectacle Fitover, Clear - 00818806020333 Catalog Number :

Device Description : Post Op Spectacle Fitover, Clear, Medium-Small

Device Class : 1

Duns Number: 052054413

Premarket Exempt : Yes

Product Code : HQY

Prescription Use : No

Device Count : 1

Post Op Spectacle Fitover, Clear - 00818806020340 Catalog Number :

Device Description : Post Op Spectacle Fitover, Clear, Medium

Device Class : 1

Duns Number: 052054413

Premarket Exempt : Yes

Product Code : HQY

Prescription Use : No

Device Count : 1

Post Op Spectacle Fitover, Clear - 00818806020357 Catalog Number :

Device Description : Post Op Spectacle Fitover, Clear, Medium-Large

Device Class : 1

Duns Number: 052054413

Premarket Exempt : Yes

Product Code : HQY

Prescription Use : No

Device Count : 1

Post Op Spectacle Fitover, Clear - 00818806020364 Catalog Number :

Device Description : Post Op Spectacle Fitover, Clear, Large

Device Class : 1

Duns Number: 052054413

Premarket Exempt : Yes

Product Code : HQY

Prescription Use : No

Device Count : 1

Post Op Spectacle Fitover, Clear - 00818806020371 Catalog Number :

Device Description : Post Op Spectacle Fitover, Clear, Xtra Large

Device Class : 1

Duns Number: 052054413

Premarket Exempt : Yes

Product Code : HQY

Prescription Use : No

Device Count : 1

Post Op Spectacle Fitover, Clear - 00818806020388 Catalog Number :

Device Description : Post Op Spectacle Fitover, Clear, Small

Device Class : 1

Duns Number: 052054413

Premarket Exempt : Yes

Product Code : HQY

Prescription Use : No

Device Count : 1

Post Op Spectacle Fitover, Tinted - 00818806020395 Catalog Number :

Device Description : Post Op Spectacle Fitover, Tinted, Medium-Small

Device Class : 1

Duns Number: 052054413

Premarket Exempt : Yes

Product Code : HQY

Prescription Use : No

Device Count : 1

Post Op Spectacle Fitover, Tinted - 00818806020401 Catalog Number :

Device Description : Post Op Spectacle Fitover, Tinted, Medium

Device Class : 1

Duns Number: 052054413

Premarket Exempt : Yes

Product Code : HQY

Prescription Use : No

Device Count : 1

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