FDA.reportPublic FDA data

RxSight Light Adjustable Lens (RxLAL)

Primary DI
00818806020135
Brand
RxSight Light Adjustable Lens (RxLAL)
Company
RXSIGHT, INC.
Model
60005-2180
Device description
LAL, Sterile, Packaged, 18.0 Diopter
Published
2019-04-01
Public version status
Update
Distribution status
Not 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
P160055002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160055002LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)Rxsight, Inc.2017-11-22PZK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818806020135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818806020135008188060201358188060201350818806020135

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
00818806022481Light Adjustable Lens (LAL)60005-30022025-10-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818806022481Light Adjustable Lens (LAL)RXSIGHT, INC.PZK2025-10-17
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