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FDA 510(k)

JOULE CLEARSENSE LASER SYSTEM

K-Number: K111483 · 2011-12-07

ApplicantSciton, Inc
Decision Date2011-12-07
Product CodePDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JOULE CLEARSENSE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sciton, Inc. It received FDA 510(k) clearance on 2011-12-07 under 510(k) number K111483. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOULE CLEARSENSE LASER SYSTEM?

JOULE CLEARSENSE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-07. The listed applicant is Sciton, Inc. The 510(k) number is K111483.

When did JOULE CLEARSENSE LASER SYSTEM receive FDA 510(k) clearance?

JOULE CLEARSENSE LASER SYSTEM received FDA 510(k) clearance on 2011-12-07, under 510(k) number K111483.

Who is the listed applicant for JOULE CLEARSENSE LASER SYSTEM?

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

What is the FDA product code for JOULE CLEARSENSE LASER SYSTEM?

The FDA product code for JOULE CLEARSENSE LASER SYSTEM is PDZ.

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Other records listing Sciton, Inc 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.

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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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