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FDA 510(k)

AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES

K-Number: K954316 · 1995-12-15

ApplicantPremier Laser Systems, Inc.
Decision Date1995-12-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Premier Laser Systems, Inc.. It received FDA 510(k) clearance on 1995-12-15 under 510(k) number K954316. 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 AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES?

AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-12-15. The listed applicant is Premier Laser Systems, Inc.. The 510(k) number is K954316.

When did AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES receive FDA 510(k) clearance?

AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES received FDA 510(k) clearance on 1995-12-15, under 510(k) number K954316.

Who is the listed applicant for AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES?

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

What is the FDA product code for AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES?

The FDA product code for AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES is GEX. This falls under the Gastroenterology category.

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Other records listing Premier Laser Systems, 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.

K993285AURORA SLK992374AURORA HLK992620BLULAZEK981379AURORAK983211CENTAURIK980559PEGASUS ND:YAG LASER SYSTEM

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Related Devices (Code: GEX)

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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