Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR

K-Number: K904366 · 1990-10-19

ApplicantDouglas James Donaldson Compliance Services
Decision Date1990-10-19
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Douglas James Donaldson Compliance Services. It received FDA 510(k) clearance on 1990-10-19 under 510(k) number K904366. 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 CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR?

CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1990-10-19. The listed applicant is Douglas James Donaldson Compliance Services. The 510(k) number is K904366.

When did CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR receive FDA 510(k) clearance?

CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR received FDA 510(k) clearance on 1990-10-19, under 510(k) number K904366.

Who is the listed applicant for CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR?

The FDA 510(k) record lists Douglas James Donaldson Compliance Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR?

The FDA product code for CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR is HQF.

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 Douglas James Donaldson Compliance Services 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.

K912987CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODEK912284BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIFK905453CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HANDK905115BIOVISION ENDOCULAR PROBE

Related Devices (Code: HQF)

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.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

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.

↑