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FDA 510(k)

PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.

K-Number: K901605 · 1990-12-13

ApplicantPhoenix Laser Systems, Inc.
Decision Date1990-12-13
Product CodeLXS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Laser Systems, Inc.. It received FDA 510(k) clearance on 1990-12-13 under 510(k) number K901605. The device is classified under product code LXS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.?

PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. is a medical device that received FDA 510(k) clearance on 1990-12-13. The listed applicant is Phoenix Laser Systems, Inc.. The 510(k) number is K901605.

When did PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. receive FDA 510(k) clearance?

PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. received FDA 510(k) clearance on 1990-12-13, under 510(k) number K901605.

Who is the listed applicant for PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.?

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

What is the FDA product code for PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.?

The FDA product code for PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. is LXS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: LXS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K023045MICRORUPTER VMeridian AGK895864MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMPLasag AGK893987NIDEK MODEL YC-1200Nidek, Inc.K892204NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERSNidek, Inc.K892058ISL QC 2000Intelligent Surgical Lasers, Inc.

Official Source

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

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