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FDA 510(k)

CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM

K-Number: K100726 · 2010-09-15

ApplicantBiolitec, Inc.
Decision Date2010-09-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec, Inc.. It received FDA 510(k) clearance on 2010-09-15 under 510(k) number K100726. 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/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM?

CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM is a medical device that received FDA 510(k) clearance on 2010-09-15. The listed applicant is Biolitec, Inc.. The 510(k) number is K100726.

When did CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM receive FDA 510(k) clearance?

CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM received FDA 510(k) clearance on 2010-09-15, under 510(k) number K100726.

Who is the listed applicant for CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM?

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/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM?

The FDA product code for CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM 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 KITK090164CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER

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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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