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FDA 510(k)

CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50)

K-Number: K951775 · 1995-07-17

ApplicantCeram Optec, Inc.
Decision Date1995-07-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) is the device name listed in this FDA 510(k) record. The listed applicant is Ceram Optec, Inc.. It received FDA 510(k) clearance on 1995-07-17 under 510(k) number K951775. 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 DIODE LASER SYSTEM (MODEL CERALAS D50)?

CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) is a medical device that received FDA 510(k) clearance on 1995-07-17. The listed applicant is Ceram Optec, Inc.. The 510(k) number is K951775.

When did CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) receive FDA 510(k) clearance?

CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) received FDA 510(k) clearance on 1995-07-17, under 510(k) number K951775.

Who is the listed applicant for CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50)?

The FDA 510(k) record lists Ceram Optec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50)?

The FDA product code for CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) is GEX. This falls under the Gastroenterology category.

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Other records listing Ceram Optec, 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.

K002296CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15K001975CERALAS D10 810NM LASER, MODEL CERALAS D10-60K993911CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50K993828CERALAS D10 810NM DIODE LASERK993002CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15K992773CERALAS D10 810NM DIODE LASER

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Related Devices (Code: GEX)

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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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