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FDA 510(k)

A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5

K-Number: K002986 · 2000-11-29

ApplicantA.R.C. Laser AG
Decision Date2000-11-29
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 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 2000-11-29 under 510(k) number K002986. 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 A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5?

A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 is a medical device that received FDA 510(k) clearance on 2000-11-29. The listed applicant is A.R.C. Laser AG. The 510(k) number is K002986.

When did A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 receive FDA 510(k) clearance?

A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 received FDA 510(k) clearance on 2000-11-29, under 510(k) number K002986.

Who is the listed applicant for A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5?

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 A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5?

The FDA product code for A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 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.

K003512LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK IIK001511O-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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