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)

SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR

K-Number: K070776 · 2007-04-24

Decision Date2007-04-24
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2007-04-24 under 510(k) number K070776. 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 SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR?

SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 2007-04-24. The listed applicant is Quantel Medical. The 510(k) number is K070776.

When did SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR receive FDA 510(k) clearance?

SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR received FDA 510(k) clearance on 2007-04-24, under 510(k) number K070776.

Who is the listed applicant for SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR?

The FDA 510(k) record lists Quantel Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR?

The FDA product code for SUPRA OPHTHALMIC 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.

Other records listing Quantel Medical 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.

View all 29 devices →

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.

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.

↑