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FDA 510(k)

LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER

K-Number: K091675 · 2009-12-15

ApplicantReimers and Janssen GmbH
Decision Date2009-12-15
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER is the device name listed in this FDA 510(k) record. The listed applicant is Reimers and Janssen GmbH. It received FDA 510(k) clearance on 2009-12-15 under 510(k) number K091675. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER?

LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER is a medical device that received FDA 510(k) clearance on 2009-12-15. The listed applicant is Reimers and Janssen GmbH. The 510(k) number is K091675.

When did LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER receive FDA 510(k) clearance?

LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER received FDA 510(k) clearance on 2009-12-15, under 510(k) number K091675.

Who is the listed applicant for LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER?

The FDA 510(k) record lists Reimers and Janssen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER?

The FDA product code for LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER is ILY.

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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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