FDA 510(k)

CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT

K-Number: K030700 · 2003-06-04

Decision Date2003-06-04

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec, Inc.. It received FDA 510(k) clearance on 2003-06-04 under 510(k) number K030700. 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 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT?

CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT is a medical device that received FDA 510(k) clearance on 2003-06-04. The listed applicant is Biolitec, Inc.. The 510(k) number is K030700.

When did CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT receive FDA 510(k) clearance?

CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT received FDA 510(k) clearance on 2003-06-04, under 510(k) number K030700.

Who is the listed applicant for CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT?

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 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT?

The FDA product code for CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT is GEX. This falls under the Gastroenterology category.

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Other records listing Biolitec, Inc. as applicant

K112013EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER K112253CERALAS 147NM DIODE LASER SYSTEM K110080RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM K102755CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER K101712ENDOVASCULAR LAER VEIN SYSTEM KIT K100726CERALAS 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.