RxSight Light Delivery Device (LDD)

GUDID 00818806020029

Light Delivery Device

RXSIGHT, INC.

Ophthalmic slit lamp, examination

• Primary Device ID: 00818806020029
• NIH Device Record Key: 646cda7e-c886-4ea0-8a5d-f6183fbe346c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RxSight Light Delivery Device (LDD)
• Version Model Number: 61002
• Company DUNS: 052054413
• Company Name: RXSIGHT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00818806020029 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-16
• Device Publish Date: 2019-04-08

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