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FDA 510(k)

LASER PHOTONICS ML755 DERMABLASER

K-Number: K934501 · 1994-08-30

ApplicantLaser Photonics, Inc.
Decision Date1994-08-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER PHOTONICS ML755 DERMABLASER is the device name listed in this FDA 510(k) record. The listed applicant is Laser Photonics, Inc.. It received FDA 510(k) clearance on 1994-08-30 under 510(k) number K934501. 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 LASER PHOTONICS ML755 DERMABLASER?

LASER PHOTONICS ML755 DERMABLASER is a medical device that received FDA 510(k) clearance on 1994-08-30. The listed applicant is Laser Photonics, Inc.. The 510(k) number is K934501.

When did LASER PHOTONICS ML755 DERMABLASER receive FDA 510(k) clearance?

LASER PHOTONICS ML755 DERMABLASER received FDA 510(k) clearance on 1994-08-30, under 510(k) number K934501.

Who is the listed applicant for LASER PHOTONICS ML755 DERMABLASER?

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

What is the FDA product code for LASER PHOTONICS ML755 DERMABLASER?

The FDA product code for LASER PHOTONICS ML755 DERMABLASER is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Photonics, Inc. as applicant

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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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