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FDA 510(k)

SCITON IMAGE HAIR REMOVAL LASER

K-Number: K002853 · 2000-12-04

ApplicantSciton, Inc
Decision Date2000-12-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCITON IMAGE HAIR REMOVAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Sciton, Inc. It received FDA 510(k) clearance on 2000-12-04 under 510(k) number K002853. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCITON IMAGE HAIR REMOVAL LASER?

SCITON IMAGE HAIR REMOVAL LASER is a medical device that received FDA 510(k) clearance on 2000-12-04. The listed applicant is Sciton, Inc. The 510(k) number is K002853.

When did SCITON IMAGE HAIR REMOVAL LASER receive FDA 510(k) clearance?

SCITON IMAGE HAIR REMOVAL LASER received FDA 510(k) clearance on 2000-12-04, under 510(k) number K002853.

Who is the listed applicant for SCITON IMAGE HAIR REMOVAL LASER?

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 SCITON IMAGE HAIR REMOVAL LASER?

The FDA product code for SCITON IMAGE HAIR REMOVAL LASER is GEX. This falls under the Gastroenterology category.

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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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