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FDA 510(k)

ELLIPSE LIGHT SPT

K-Number: K043255 · 2005-02-24

ApplicantDanish Dermatologic Development A/S
Decision Date2005-02-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELLIPSE LIGHT SPT is the device name listed in this FDA 510(k) record. The listed applicant is Danish Dermatologic Development A/S. It received FDA 510(k) clearance on 2005-02-24 under 510(k) number K043255. 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 ELLIPSE LIGHT SPT?

ELLIPSE LIGHT SPT is a medical device that received FDA 510(k) clearance on 2005-02-24. The listed applicant is Danish Dermatologic Development A/S. The 510(k) number is K043255.

When did ELLIPSE LIGHT SPT receive FDA 510(k) clearance?

ELLIPSE LIGHT SPT received FDA 510(k) clearance on 2005-02-24, under 510(k) number K043255.

Who is the listed applicant for ELLIPSE LIGHT SPT?

The FDA 510(k) record lists Danish Dermatologic Development A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELLIPSE LIGHT SPT?

The FDA product code for ELLIPSE LIGHT SPT is GEX. This falls under the Gastroenterology category.

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Other records listing Danish Dermatologic Development A/S 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.

K060516ELLIPSE 12PL, MODEL 9ESL7228K052688ELLIPSE FLEX PPT, MODEL 9ESF7255

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

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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