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FDA 510(k)

SLASE 210 PLUS HOLMIUM LASER SYSTEM

K-Number: K945156 · 1995-03-09

ApplicantNew Star Lasers, Inc.
Decision Date1995-03-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SLASE 210 PLUS HOLMIUM LASER SYSTEM 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 1995-03-09 under 510(k) number K945156. 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 SLASE 210 PLUS HOLMIUM LASER SYSTEM?

SLASE 210 PLUS HOLMIUM LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-09. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K945156.

When did SLASE 210 PLUS HOLMIUM LASER SYSTEM receive FDA 510(k) clearance?

SLASE 210 PLUS HOLMIUM LASER SYSTEM received FDA 510(k) clearance on 1995-03-09, under 510(k) number K945156.

Who is the listed applicant for SLASE 210 PLUS HOLMIUM LASER SYSTEM?

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 SLASE 210 PLUS HOLMIUM LASER SYSTEM?

The FDA product code for SLASE 210 PLUS HOLMIUM LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing New Star Lasers, 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.

K103338COOLTOUCHK101783COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZEK092964COOLTOUCH VARIA ND:YAG LASER SYSTEMK090410COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORYK081628MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPOK080163COOLTOUCH MODELS LC215 AND COOLLIPO

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Related Devices (Code: GEX)

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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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