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FDA 510(k)

ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE

K-Number: K950215 · 1995-06-15

ApplicantReliant Laser Corp.
Decision Date1995-06-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Reliant Laser Corp.. It received FDA 510(k) clearance on 1995-06-15 under 510(k) number K950215. 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 ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE?

ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE is a medical device that received FDA 510(k) clearance on 1995-06-15. The listed applicant is Reliant Laser Corp.. The 510(k) number is K950215.

When did ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE receive FDA 510(k) clearance?

ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE received FDA 510(k) clearance on 1995-06-15, under 510(k) number K950215.

Who is the listed applicant for ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE?

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

What is the FDA product code for ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE?

The FDA product code for ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE is GEX. This falls under the Gastroenterology category.

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Other records listing Reliant Laser Corp. 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.

K942868ACUTOME 2000 COLOR-CORRECTED LAPAROSCOPIC C02 LASER COUPLER AND SLEEVESK920821UNIMAX MODEL 2000 COLOR-CORRECTED MICROSPOT CO2

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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