Light Adjustable Lens (LAL)

GUDID 00818806021392

LAL+, Light Adjustable Lens, Sterile, Packaged, 6.0 Diopter

RXSIGHT, INC.

Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 00818806021392
• NIH Device Record Key: eb1056e2-1bec-4ed5-a21a-d21936aea4f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Light Adjustable Lens (LAL)
• Version Model Number: 60007-0060
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818806021392 [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: 2023-05-09
• Device Publish Date: 2023-05-01

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

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