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FDA 510(k)

CERALAS D DIODE LASER SYSTEM, MODEL # D50

K-Number: K013691 · 2002-08-13

ApplicantBiolitec, Inc.
Decision Date2002-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERALAS D DIODE LASER SYSTEM, MODEL # D50 is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec, Inc.. It received FDA 510(k) clearance on 2002-08-13 under 510(k) number K013691. 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 CERALAS D DIODE LASER SYSTEM, MODEL # D50?

CERALAS D DIODE LASER SYSTEM, MODEL # D50 is a medical device that received FDA 510(k) clearance on 2002-08-13. The listed applicant is Biolitec, Inc.. The 510(k) number is K013691.

When did CERALAS D DIODE LASER SYSTEM, MODEL # D50 receive FDA 510(k) clearance?

CERALAS D DIODE LASER SYSTEM, MODEL # D50 received FDA 510(k) clearance on 2002-08-13, under 510(k) number K013691.

Who is the listed applicant for CERALAS D DIODE LASER SYSTEM, MODEL # D50?

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

What is the FDA product code for CERALAS D DIODE LASER SYSTEM, MODEL # D50?

The FDA product code for CERALAS D DIODE LASER SYSTEM, MODEL # D50 is GEX. This falls under the Gastroenterology category.

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Other records listing Biolitec, 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.

K112013EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASERK112253CERALAS 147NM DIODE LASER SYSTEMK110080RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEMK102755CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASERK101712ENDOVASCULAR LAER VEIN SYSTEM KITK100726CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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