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FDA 510(k)

MODIFICATION TO PROLITE PULSED LIGHT SYSTEM

K-Number: K010927 · 2001-06-19

ApplicantMedical Bio Care Sweden AB
Decision Date2001-06-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PROLITE PULSED LIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Bio Care Sweden AB. It received FDA 510(k) clearance on 2001-06-19 under 510(k) number K010927. 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 MODIFICATION TO PROLITE PULSED LIGHT SYSTEM?

MODIFICATION TO PROLITE PULSED LIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-19. The listed applicant is Medical Bio Care Sweden AB. The 510(k) number is K010927.

When did MODIFICATION TO PROLITE PULSED LIGHT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO PROLITE PULSED LIGHT SYSTEM received FDA 510(k) clearance on 2001-06-19, under 510(k) number K010927.

Who is the listed applicant for MODIFICATION TO PROLITE PULSED LIGHT SYSTEM?

The FDA 510(k) record lists Medical Bio Care Sweden AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO PROLITE PULSED LIGHT SYSTEM?

The FDA product code for MODIFICATION TO PROLITE PULSED LIGHT SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Medical Bio Care Sweden AB 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.

K023081PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)K022378PLASMALITE PULSED LIGHT SYSTEMK022568PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIRK022569PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONSK013365PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOSK013366PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR

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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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