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FDA 510(k)

LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II

K-Number: K003512 · 2001-02-08

ApplicantA.R.C. Laser AG
Decision Date2001-02-08
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II is the device name listed in this FDA 510(k) record. The listed applicant is A.R.C. Laser AG. It received FDA 510(k) clearance on 2001-02-08 under 510(k) number K003512. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II?

LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II is a medical device that received FDA 510(k) clearance on 2001-02-08. The listed applicant is A.R.C. Laser AG. The 510(k) number is K003512.

When did LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II receive FDA 510(k) clearance?

LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II received FDA 510(k) clearance on 2001-02-08, under 510(k) number K003512.

Who is the listed applicant for LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II?

The FDA 510(k) record lists A.R.C. Laser AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II?

The FDA product code for LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II is HQC.

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.

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Other records listing A.R.C. Laser AG 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.

K002986A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5K001511O-LAS OPHTHALMIC PHOTODISRUPTOR

Related Devices (Code: HQC)

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.

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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.

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