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FDA 510(k)

ARAMIS II DERMATOLOGICAL LASER

K-Number: K023734 · 2003-05-06

ApplicantQuantel Medical
Decision Date2003-05-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARAMIS II DERMATOLOGICAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2003-05-06 under 510(k) number K023734. 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 ARAMIS II DERMATOLOGICAL LASER?

ARAMIS II DERMATOLOGICAL LASER is a medical device that received FDA 510(k) clearance on 2003-05-06. The listed applicant is Quantel Medical. The 510(k) number is K023734.

When did ARAMIS II DERMATOLOGICAL LASER receive FDA 510(k) clearance?

ARAMIS II DERMATOLOGICAL LASER received FDA 510(k) clearance on 2003-05-06, under 510(k) number K023734.

Who is the listed applicant for ARAMIS II DERMATOLOGICAL LASER?

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

What is the FDA product code for ARAMIS II DERMATOLOGICAL LASER?

The FDA product code for ARAMIS II DERMATOLOGICAL 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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