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FDA 510(k)

MEDLITE LASER SYSTEM

K-Number: K952636 · 1995-07-31

ApplicantContinuum Biomedical, Inc.
Decision Date1995-07-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDLITE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Continuum Biomedical, Inc.. It received FDA 510(k) clearance on 1995-07-31 under 510(k) number K952636. 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 MEDLITE LASER SYSTEM?

MEDLITE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1995-07-31. The listed applicant is Continuum Biomedical, Inc.. The 510(k) number is K952636.

When did MEDLITE LASER SYSTEM receive FDA 510(k) clearance?

MEDLITE LASER SYSTEM received FDA 510(k) clearance on 1995-07-31, under 510(k) number K952636.

Who is the listed applicant for MEDLITE LASER SYSTEM?

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

What is the FDA product code for MEDLITE LASER SYSTEM?

The FDA product code for MEDLITE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Continuum Biomedical, Inc. 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.

K992013DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASERK983054MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASERK973719MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASERK970808MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASERK971903SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASERK971879SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER

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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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