Sensitive Eyes Saline Solution

FDA PMAFDA 510(k)

Class II (US FDA PMA)

PMA P810039510(k) K832706

by Bausch & Lomb, Inc.

Identity

Trade Name: SENSITIVE EYES(TM) SALINE SOLUTION FDA PMA
Generic Name: Accessories, soft lens products FDA PMA

Identifiers

PMA Number: P810039 FDA PMA
510(k) Number: K832706 FDA PMA
FDA Product Code: HPX FDA PMA

Classification

Device Class: U FDA PMA
Advisory Committee: Unknown FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA
PMA Supplement: S001 FDA PMA

Sensitive Eyes Saline Solution is an accessory for soft lens products, specifically designed for use with contact lenses. It is a sterile saline solution intended for rinsing and storing soft contact lenses.

The solution is supplied as a single-use or multi-use product depending on packaging, and is intended for use in home or clinical settings. It is not MRI conditional unless explicitly stated, and should be stored according to label instructions. Authorization includes FDA 510(k) clearance K832706 and PMA P810039.

Frequently asked questions

What is the generic name of Sensitive Eyes Saline Solution?

The generic name is Accessories, soft lens products, as specified in the device data under the generic_name field.

What FDA authorizations are associated with this device?

The device has both FDA 510(k) clearance (K832706) and FDA PMA approval (P810039), as listed in the AUTHORIZATIONS and openfda fields.

Is Sensitive Eyes Saline Solution intended for use with hard or soft contact lenses?

It is intended for use with soft contact lenses, as indicated by the generic_name 'Accessories, soft lens products' and the device_name 'SENSITIVE EYES' in the context of contact lens care.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K832706	Class II	Active
FDA PMA	United States	FDA_PMA	P810039	Class II	Active

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Manufacturer

Manufacturer: Bausch & Lomb, Inc.

Sources (2)

FDA PMA P810039 36 fields · synced Sep 18, 2026
FDA 510(k) K832706 1 fields · synced May 18, 2026