FDA 510(k)

ISL QC 2000

K-Number: K892058 · 1989-06-15

ApplicantIntelligent Surgical Lasers, Inc.

Decision Date1989-06-15

Product CodeLXS

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

ISL QC 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Surgical Lasers, Inc.. It received FDA 510(k) clearance on 1989-06-15 under 510(k) number K892058. 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 ISL QC 2000?

ISL QC 2000 is a medical device that received FDA 510(k) clearance on 1989-06-15. The listed applicant is Intelligent Surgical Lasers, Inc.. The 510(k) number is K892058.

When did ISL QC 2000 receive FDA 510(k) clearance?

ISL QC 2000 received FDA 510(k) clearance on 1989-06-15, under 510(k) number K892058.

Who is the listed applicant for ISL QC 2000?

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

What is the FDA product code for ISL QC 2000?

The FDA product code for ISL QC 2000 is LXS.

Other records listing Intelligent Surgical Lasers, Inc. as applicant

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.

K941694ISL QC 2000 LASER

Related Devices (Code: LXS)

K023045MICRORUPTER VMeridian AG K901605PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.Phoenix Laser Systems, Inc.K895864MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMPLasag AG K893987NIDEK MODEL YC-1200Nidek, Inc.K892204NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERSNidek, 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.