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FDA 510(k)

CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60

K-Number: K020835 · 2002-06-12

ApplicantBiolitec, Inc.
Decision Date2002-06-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec, Inc.. It received FDA 510(k) clearance on 2002-06-12 under 510(k) number K020835. 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 D10-60 810NM DIODE LASER, MODELCERALAS DIO-60?

CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 is a medical device that received FDA 510(k) clearance on 2002-06-12. The listed applicant is Biolitec, Inc.. The 510(k) number is K020835.

When did CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 receive FDA 510(k) clearance?

CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 received FDA 510(k) clearance on 2002-06-12, under 510(k) number K020835.

Who is the listed applicant for CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60?

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 D10-60 810NM DIODE LASER, MODELCERALAS DIO-60?

The FDA product code for CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 is GEX. This falls under the Gastroenterology category.

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Official Source

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