Light Adjustable Lens (LAL)

GUDID 00818806021415

LAL+, Light Adjustable Lens, Sterile, Packaged, 8.0 Diopter

RXSIGHT, INC.

Posterior-chamber intraocular lens, pseudophakic
Primary Device ID00818806021415
NIH Device Record Keyd2b6754d-ac62-4dc7-8911-96b78279e774
Commercial Distribution StatusIn Commercial Distribution
Brand NameLight Adjustable Lens (LAL)
Version Model Number60007-0080
Company DUNS052054413
Company NameRXSIGHT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100818806021415 [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 Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-09
Device Publish Date2023-05-01

On-Brand Devices [Light Adjustable Lens (LAL)]

00818806021729LAL+, Light Adjustable Lens, Sterile, Packaged, 30.0 Diopter
00818806021712LAL+, Light Adjustable Lens, Sterile, Packaged, 29.0 Diopter
00818806021705LAL+, Light Adjustable Lens, Sterile, Packaged, 28.0 Diopter
00818806021699LAL+, Light Adjustable Lens, Sterile, Packaged, 27.0 Diopter
00818806021682LAL+, Light Adjustable Lens, Sterile, Packaged, 26.0 Diopter
00818806021675LAL+, Light Adjustable Lens, Sterile, Packaged, 25.0 Diopter
00818806021668LAL+, Light Adjustable Lens, Sterile, Packaged, 24.0 Diopter
00818806021651LAL+, Light Adjustable Lens, Sterile, Packaged, 23.5 Diopter
00818806021644LAL+, Light Adjustable Lens, Sterile, Packaged, 23.0 Diopter
00818806021637LAL+, Light Adjustable Lens, Sterile, Packaged, 22.5 Diopter
00818806021620LAL+, Light Adjustable Lens, Sterile, Packaged, 22.0 Diopter
00818806021613LAL+, Light Adjustable Lens, Sterile, Packaged, 21.5 Diopter
00818806021606LAL+, Light Adjustable Lens, Sterile, Packaged, 21.0 Diopter
00818806021590LAL+, Light Adjustable Lens, Sterile, Packaged, 20.5 Diopter
00818806021583LAL+, Light Adjustable Lens, Sterile, Packaged, 20.0 Diopter
00818806021576LAL+, Light Adjustable Lens, Sterile, Packaged, 19.5 Diopter
00818806021569LAL+, Light Adjustable Lens, Sterile, Packaged, 19.0 Diopter
00818806021552LAL+, Light Adjustable Lens, Sterile, Packaged, 18.5 Diopter
00818806021545LAL+, Light Adjustable Lens, Sterile, Packaged, 18.0 Diopter
00818806021538LAL+, Light Adjustable Lens, Sterile, Packaged, 17.5 Diopter
00818806021521LAL+, Light Adjustable Lens, Sterile, Packaged, 17.0 Diopter
00818806021514LAL+, Light Adjustable Lens, Sterile, Packaged, 16.5 Diopter
00818806021507LAL+, Light Adjustable Lens, Sterile, Packaged, 16.0 Diopter
00818806021491LAL+, Light Adjustable Lens, Sterile, Packaged, 15.0 Diopter
00818806021477LAL+, Light Adjustable Lens, Sterile, Packaged, 14.0 Diopter
00818806021460LAL+, Light Adjustable Lens, Sterile, Packaged, 13.0 Diopter
00818806021453LAL+, Light Adjustable Lens, Sterile, Packaged, 12.0 Diopter
00818806021446LAL+, Light Adjustable Lens, Sterile, Packaged, 11.0 Diopter
00818806021439LAL, Sterile, Packaged, 5.0 Diopter
00818806021422LAL+, Light Adjustable Lens, Sterile, Packaged, 9.0 Diopter
00818806021415LAL+, Light Adjustable Lens, Sterile, Packaged, 8.0 Diopter
00818806021408LAL+, Light Adjustable Lens, Sterile, Packaged, 7.0 Diopter
00818806021392LAL+, Light Adjustable Lens, Sterile, Packaged, 6.0 Diopter
00818806021385LAL+, Light Adjustable Lens, Sterile, Packaged, 5.0 Diopter
00818806021378LAL+, Light Adjustable Lens, Sterile, Packaged, 4.0 Diopter
00818806021743LAL+, Light Adjustable Lens, Sterile, Packaged, -2.0 Diopter
00818806021736LAL+, Light Adjustable Lens, Sterile, Packaged, -1.0 Diopter
00818806021484LAL+, Light Adjustable Lens, Sterile, Packaged, 0.0 Diopter
00818806020951LAL+, Light Adjustable Lens, Sterile, Packaged, 1.0 Diopter
00818806020869LAL+, Light Adjustable Lens, Sterile, Packaged, 2.0 Diopter
00818806020852LAL+, Light Adjustable Lens, Sterile, Packaged, 3.0 Diopter
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