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FDA 510(k)

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)

K-Number: K223132 · 2022-11-09

ApplicantIridex Corporation
Decision Date2022-11-09
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) is a medical device manufactured by Iridex Corporation. It received FDA 510(k) clearance on 2022-11-09 under approval number K223132. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)?

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) is a medical device that received FDA 510(k) clearance on 2022-11-09. It is manufactured by Iridex Corporation. The 510(k) number is K223132.

When was Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) approved by the FDA?

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) received FDA 510(k) clearance on 2022-11-09, under approval number K223132.

What company makes Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)?

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) is manufactured by Iridex Corporation.

What is the FDA product code for Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)?

The FDA product code for Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) is HQF.

Other Devices by Iridex Corporation

K162416IRIDEX Cyclo G6 Laser System, G-Probe Illuminate K170718Iridex TruFocus LIO Premiere K181662Iridex TruFocus LIO Premiere K202760Iridex 810 Laser K213592Iridex 810 Laser K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)

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Related Devices (Code: HQF)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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