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FDA 510(k)

STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT

K-Number: K851936 · 1985-08-20

ApplicantStaar Surgical Co.
Decision Date1985-08-20
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT is the device name listed in this FDA 510(k) record. The listed applicant is Staar Surgical Co.. It received FDA 510(k) clearance on 1985-08-20 under 510(k) number K851936. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT?

STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT is a medical device that received FDA 510(k) clearance on 1985-08-20. The listed applicant is Staar Surgical Co.. The 510(k) number is K851936.

When did STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT receive FDA 510(k) clearance?

STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT received FDA 510(k) clearance on 1985-08-20, under 510(k) number K851936.

Who is the listed applicant for STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT?

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

What is the FDA product code for STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT?

The FDA product code for STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT is HQE.

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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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