RxSight Light Delivery Device (LDD)

GUDID 00818806020029

Light Delivery Device

RXSIGHT, INC.

Ophthalmic slit lamp, examination
Primary Device ID00818806020029
NIH Device Record Key646cda7e-c886-4ea0-8a5d-f6183fbe346c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRxSight Light Delivery Device (LDD)
Version Model Number61002
Company DUNS052054413
Company NameRXSIGHT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100818806020029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZKLight Adjustable Lens (Lal) And Light Delivery Device (Ldd)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-16
Device Publish Date2019-04-08

Devices Manufactured by RXSIGHT, INC.

00818806021378 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 4.0 Diopter
00818806021385 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 5.0 Diopter
00818806021392 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 6.0 Diopter
00818806021408 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 7.0 Diopter
00818806021415 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 8.0 Diopter
00818806021422 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 9.0 Diopter
00818806021439 - Light Adjustable Lens (LAL)2023-05-09 LAL, Sterile, Packaged, 5.0 Diopter
00818806021446 - Light Adjustable Lens (LAL)2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 11.0 Diopter

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