RxSight Contact Lens

GUDID 00818806020531

RxSight Contact Lens

RXSIGHT, INC.

Vitrectomy contact lens, reusable Vitrectomy contact lens, reusable Vitrectomy contact lens, reusable Vitrectomy contact lens, reusable Vitrectomy contact lens, reusable Vitrectomy contact lens, reusable Vitrectomy contact lens, reusable Vitrectomy contact lens, reusable Vitrectomy contact lens, reusable

• Primary Device ID: 00818806020531
• NIH Device Record Key: 156af276-c6b8-477f-b143-ddc701a765f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RxSight Contact Lens
• Version Model Number: 62020
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818806020531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201909

FDA Product Code

• HJK: Lens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-26
• Device Publish Date: 2020-10-16

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