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FDA 510(k)

NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160

K-Number: K023962 · 2002-12-24

ApplicantNew Star Lasers, Inc.
Decision Date2002-12-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 is the device name listed in this FDA 510(k) record. The listed applicant is New Star Lasers, Inc.. It received FDA 510(k) clearance on 2002-12-24 under 510(k) number K023962. 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 NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160?

NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 is a medical device that received FDA 510(k) clearance on 2002-12-24. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K023962.

When did NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 receive FDA 510(k) clearance?

NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 received FDA 510(k) clearance on 2002-12-24, under 510(k) number K023962.

Who is the listed applicant for NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160?

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

What is the FDA product code for NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160?

The FDA product code for NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 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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