RxSight Light Adjustable Lens (RxLAL)

GUDID 00818806020159

LAL, Sterile, Packaged, 19.0 Diopter

RXSIGHT, INC.

Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 00818806020159
• NIH Device Record Key: 51119355-f6f9-42fe-93f6-621fb5e2f594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RxSight Light Adjustable Lens (RxLAL)
• Version Model Number: 60005-2190
• Company DUNS: 052054413
• Company Name: RXSIGHT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818806020159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160055

FDA Product Code

• PZK: Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-04-01

On-Brand Devices [RxSight Light Adjustable Lens (RxLAL)]

• 00818806020319: LAL, Sterile, Packaged, 30.0 Diopter
• 00818806020302: LAL, Sterile, Packaged, 29.0 Diopter
• 00818806020296: LAL, Sterile, Packaged, 28.0 Diopter
• 00818806020289: LAL, Sterile, Packaged, 27.0 Diopter
• 00818806020272: LAL, Sterile, Packaged, 26.0 Diopter
• 00818806020265: LAL, Sterile, Packaged, 25.0 Diopter
• 00818806020258: LAL, Sterile, Packaged, 24.0 Diopter
• 00818806020241: LAL, Sterile, Packaged, 23.5 Diopter
• 00818806020234: LAL, Sterile, Packaged, 23.0 Diopter
• 00818806020227: LAL, Sterile, Packaged, 22.5 Diopter
• 00818806020210: LAL, Sterile, Packaged, 22.0 Diopter
• 00818806020203: LAL, Sterile, Packaged, 21.5 Diopter
• 00818806020197: LAL, Sterile, Packaged, 21.0 Diopter
• 00818806020180: LAL, Sterile, Packaged, 20.5 Diopter
• 00818806020173: LAL, Sterile, Packaged, 20.0 Diopter
• 00818806020166: LAL, Sterile, Packaged, 19.5 Diopter
• 00818806020159: LAL, Sterile, Packaged, 19.0 Diopter
• 00818806020142: LAL, Sterile, Packaged, 18.5 Diopter
• 00818806020135: LAL, Sterile, Packaged, 18.0 Diopter
• 00818806020128: LAL, Sterile, Packaged, 17.5 Diopter
• 00818806020111: LAL, Sterile, Packaged, 17.0 Diopter
• 00818806020104: LAL, Sterile, Packaged, 16.5 Diopter
• 00818806020098: LAL, Sterile, Packaged, 16.0 Diopter
• 00818806020081: LAL, Sterile, Packaged, 15.0 Diopter
• 00818806020074: LAL, Sterile, Packaged, 14.0 Diopter
• 00818806020067: LAL, Sterile, Packaged, 13.0 Diopter
• 00818806020050: LAL, Sterile, Packaged, 12.0 Diopter
• 00818806020043: LAL, Sterile, Packaged, 11.0 Diopter
• 00818806020036: LAL, Sterile, Packaged, 10.0 Diopter
• 00818806020944: LAL, Sterile, Packaged, 9.0 Diopter
• 00818806020937: LAL, Sterile, Packaged, 8.0 Diopter
• 00818806020920: LAL, Sterile, Packaged, 7.0 Diopter
• 00818806020913: LAL, Sterile, Packaged, 6.0 Diopter
• 00818806020906: LAL, Sterile, Packaged, 5.0 Diopter
• 00818806020890: LAL, Sterile, Packaged, 4.0 Diopter
• 00818806020821: LAL, Sterile, Packaged, 16.0 Diopter
• 00818806020814: LAL, Sterile, Packaged, 30.0 Diopter
• 00818806020807: LAL, Sterile, Packaged, 29.0 Diopter
• 00818806020791: LAL, Sterile, Packaged, 28.0 Diopter
• 00818806020784: LAL, Sterile, Packaged, 27.0 Diopter
• 00818806020777: LAL, Sterile, Packaged, 26.0 Diopter
• 00818806020760: LAL, Sterile, Packaged, 25.0 Diopter
• 00818806020753: LAL, Sterile, Packaged, 24.0 Diopter
• 00818806020746: LAL, Sterile, Packaged, 23.5 Diopter
• 00818806020739: LAL, Sterile, Packaged, 23.0 Diopter
• 00818806020722: LAL, Sterile, Packaged, 22.5 Diopter
• 00818806020715: LAL, Sterile, Packaged, 22.0 Diopter
• 00818806020708: LAL, Sterile, Packaged, 21.5 Diopter
• 00818806020692: LAL, Sterile, Packaged, 21.0 Diopter
• 00818806020685: LAL, Sterile, Packaged, 20.5 Diopter