Posterior Chamber Intraocular Lenses Model SP38UB

FDA PMA

Class III (US FDA PMA)

PMA P870045

by Bausch & Lomb, Inc.

Identity

Trade Name: SK15 AND SK16 FDA PMA
Generic Name: intraocular lens FDA PMA

Identifiers

PMA Number: P870045 FDA PMA
FDA Product Code: HQL FDA PMA

Classification

Device Class: Class III FDA PMA
Legislation / Framework: 21 CFR Part 886.3600 FDA PMA
Regulation Number: 886.3600 FDA PMA
Advisory Committee: Ophthalmic FDA PMA
FDA Decision: APWD FDA PMA

The Posterior Chamber Intraocular Lens Model SP38UB is an ophthalmic device manufactured by Bausch & Lomb. It is designed to function as an intraocular lens, which is a synthetic lens implanted into the eye to replace the natural lens during ophthalmic procedures.

This device is regulated as a Class 3 medical device and has received FDA PMA authorization under reference number P870045. It is intended for use by qualified medical professionals in a clinical setting. Please consult the product documentation for specific information regarding storage, handling, and clinical application.

Frequently asked questions

What is the regulatory status of the Model SP38UB?

The Model SP38UB is an FDA-authorized device, having received approval through the Premarket Approval (PMA) process under reference number P870045.

What type of device is the Model SP38UB?

The Model SP38UB is classified as an intraocular lens, which is a medical device used in ophthalmic surgery to replace the natural lens of the eye.

Who is the manufacturer of this intraocular lens?

This device is manufactured by Bausch & Lomb, Inc., based in Rochester, New York.

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_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	United States	FDA_PMA	P870045	Class III	Active

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Manufacturer

Manufacturer: Bausch & Lomb, Inc.

Sources (1)

FDA PMA P870045 24 fields · synced Sep 18, 2026