FDA.reportPublic FDA data

Light Adjustable Lens (LAL)

Primary DI
00818806022481
Brand
Light Adjustable Lens (LAL)
Company
RXSIGHT, INC.
Model
60005-3002
Device description
LAL, Light Adjustable Lens, Sterile, Packaged, -2.0 Diopter
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PZKLight Adjustable Lens (Lal) And Light Delivery Device (Ldd)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZKLight Adjustable Lens (Lal) And Light Delivery Device (Ldd)Ophthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160055043

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160055043LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)Rxsight, Inc.2017-11-22PZK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818806022481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818806022481008188060224818188060224810818806022481

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakicAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
052054413
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818806022498Light Adjustable Lens (LAL)60005-30012025-10-17
00818806022504Light Adjustable Lens (LAL)60005-30002025-10-17
00818806022511Light Adjustable Lens (LAL)60005-30102025-10-17
00818806022528Light Adjustable Lens (LAL)60005-30202025-10-17
00818806022535Light Adjustable Lens (LAL)60005-30302025-10-17
00818806021750Post Op Eyewear620262025-09-05
00818806021767Post Op Eyewear620272025-09-05
00818806021774RxSight Contact Lens62020-0022025-09-05
00818806020852Light Adjustable Lens (LAL)60007-00302024-12-04
00818806020869Light Adjustable Lens (LAL)60007-00202024-12-04
00818806020951Light Adjustable Lens (LAL)60007-00102024-12-04
00818806021484Light Adjustable Lens (LAL)60007-00002024-12-04
00818806021736Light Adjustable Lens (LAL)60007-00012024-12-04
00818806021743Light Adjustable Lens (LAL)60007-00022024-12-04
00818806020036RxSight Light Adjustable Lens (RxLAL)60005-21002019-04-01
00818806020043RxSight Light Adjustable Lens (RxLAL)60005-21102019-04-01
00818806020050RxSight Light Adjustable Lens (RxLAL)60005-21202019-04-01
00818806020067RxSight Light Adjustable Lens (RxLAL)60005-21302019-04-01
00818806020074RxSight Light Adjustable Lens (RxLAL)60005-21402019-04-01
00818806020081RxSight Light Adjustable Lens (RxLAL)60005-21502019-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818806022498Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2025-10-17
00818806022504Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2025-10-17
00818806022511Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2025-10-17
00818806022528Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2025-10-17
00818806022535Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2025-10-17
00818806020852Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2024-12-04
00818806020869Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2024-12-04
00818806020951Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2024-12-04
00818806021484Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2024-12-04
00818806021736Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2024-12-04
00818806021743Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2024-12-04
00818806021378Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021385Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021392Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021408Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021415Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021422Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021439Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021446Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021453Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021460Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021477Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021491Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021507Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021514Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021521Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021538Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021545Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021552Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01
00818806021569Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2023-05-01