RxSight Light Adjustable Lens (RxLAL)

Basic Information

• Brand Name: RxSight Light Adjustable Lens (RxLAL)
• Primary DI: 00818806020142
• Version / Model: 60005-2185
• Company Name: RXSIGHT, INC.
• Labeler DUNS: 052054413
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-01
• Public Version: 3
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: a552d51e-37f0-406a-9dc3-4187766cfa43

Device Description

LAL, Sterile, Packaged, 18.5 Diopter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PZK	Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)	Ophthalmic	886.3600	3

GMDN Terms

Code	Name	Definition	Implantable	Status
35658	Posterior-chamber intraocular lens, pseudophakic	An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818806020142	GS1

Premarket Submissions

Submission Number	Supplement Number
P160055	002

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius