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FDA 510(k)

IRIS ND:YAG OPTHALMIC LASER

K-Number: K883270 · 1988-10-13

ApplicantCalifornia Laboratories, Inc.
Decision Date1988-10-13
Product CodeLQJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRIS ND:YAG OPTHALMIC LASER is the device name listed in this FDA 510(k) record. The listed applicant is California Laboratories, Inc.. It received FDA 510(k) clearance on 1988-10-13 under 510(k) number K883270. The device is classified under product code LQJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRIS ND:YAG OPTHALMIC LASER?

IRIS ND:YAG OPTHALMIC LASER is a medical device that received FDA 510(k) clearance on 1988-10-13. The listed applicant is California Laboratories, Inc.. The 510(k) number is K883270.

When did IRIS ND:YAG OPTHALMIC LASER receive FDA 510(k) clearance?

IRIS ND:YAG OPTHALMIC LASER received FDA 510(k) clearance on 1988-10-13, under 510(k) number K883270.

Who is the listed applicant for IRIS ND:YAG OPTHALMIC LASER?

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

What is the FDA product code for IRIS ND:YAG OPTHALMIC LASER?

The FDA product code for IRIS ND:YAG OPTHALMIC LASER is LQJ.

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

Other records listing California Laboratories, 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.

K884431HEXASCAN HANDPIECE FOR ARGON/DYE LASERK884694MQL 20 ND:YAG OPHTHALMIC LASERK875338CHRYS(TM) MODEL MED-MAX

Related Devices (Code: LQJ)

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.

K163632Katalyst Cyclophotocoagulation ProbeKatalyst Surgical, LLCK931356SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTORSorenson Laboratories, Inc.K921414TROKEL /3 GONIO LASER LENSOcular Instruments, Inc.K912112PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480Tomey Corporation USAK893731SHIELDS T.C. LASER LENSOcular Instruments, Inc.K884694MQL 20 ND:YAG OPHTHALMIC LASERCalifornia Laboratories, Inc.

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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