FDA PMA

Light adjustable lens (LAL) and light delivery device (LDD)

Numéro PMA : P160055 · 2026-09-03

DemandeurRxsight, Inc.

Date de décision2026-09-03

Numéro PMAP160055

Code produitPZK

Classe de dispositifClasse 3

Spécialité médicaleO

Numéro de réglementation21 CFR 8

Comité consultatifOP

Résumé du dispositif

Light adjustable lens (LAL) and light delivery device (LDD) is the device name listed in this FDA 510(k) record. The listed applicant is Rxsight, Inc.. It received FDA 510(k) clearance on 2026-09-03. The device is classified under product code PZK. It was reviewed by the OP advisory panel.

Questions fréquentes

What is the Light adjustable lens (LAL) and light delivery device (LDD)?

Light adjustable lens (LAL) and light delivery device (LDD) is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Rxsight, Inc..

When did Light adjustable lens (LAL) and light delivery device (LDD) receive FDA 510(k) clearance?

The clearance date for Light adjustable lens (LAL) and light delivery device (LDD) can be found in the official FDA records.

Who is the listed applicant for Light adjustable lens (LAL) and light delivery device (LDD)?

The FDA 510(k) record lists Rxsight, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Light adjustable lens (LAL) and light delivery device (LDD)?

The FDA product code for Light adjustable lens (LAL) and light delivery device (LDD) is PZK.

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Source officielle

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