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FDA 510(k)

CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980

K-Number: K082263 · 2008-10-24

ApplicantBiolitec, Inc.
Decision Date2008-10-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec, Inc.. It received FDA 510(k) clearance on 2008-10-24 under 510(k) number K082263. 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 E 980NM DIODE LASER, MODELS E15/980 AND E30/980?

CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 is a medical device that received FDA 510(k) clearance on 2008-10-24. The listed applicant is Biolitec, Inc.. The 510(k) number is K082263.

When did CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 receive FDA 510(k) clearance?

CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 received FDA 510(k) clearance on 2008-10-24, under 510(k) number K082263.

Who is the listed applicant for CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980?

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 E 980NM DIODE LASER, MODELS E15/980 AND E30/980?

The FDA product code for CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

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