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FDA 510(k)

PHOTODERM HR SYSTEM

K-Number: K974536 · 1998-05-20

ApplicantEsc Medical Systems , Ltd.
Decision Date1998-05-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHOTODERM HR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Esc Medical Systems , Ltd.. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K974536. 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 PHOTODERM HR SYSTEM?

PHOTODERM HR SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Esc Medical Systems , Ltd.. The 510(k) number is K974536.

When did PHOTODERM HR SYSTEM receive FDA 510(k) clearance?

PHOTODERM HR SYSTEM received FDA 510(k) clearance on 1998-05-20, under 510(k) number K974536.

Who is the listed applicant for PHOTODERM HR SYSTEM?

The FDA 510(k) record lists Esc Medical Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHOTODERM HR SYSTEM?

The FDA product code for PHOTODERM HR SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Esc Medical Systems , Ltd. 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.

K994014ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHTK991935EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEMK982119DIODE LASERK980537ND: YAG ACCESSORY FOR PHOTODERM SYSTEMK972872DERMA K LASER SYSTEMK972028DERMASCAN SURGICAL LASER SCANNER

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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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