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FDA 510(k)

MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM

K-Number: K010689 · 2001-05-18

ApplicantBiolitec, Inc.
Decision Date2001-05-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec, Inc.. It received FDA 510(k) clearance on 2001-05-18 under 510(k) number K010689. 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 MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM?

MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Biolitec, Inc.. The 510(k) number is K010689.

When did MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM receive FDA 510(k) clearance?

MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM received FDA 510(k) clearance on 2001-05-18, under 510(k) number K010689.

Who is the listed applicant for MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM?

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 MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM?

The FDA product code for MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM 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

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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