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FDA 510(k)

ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION

K-Number: K112031 · 2011-09-13

ApplicantAlma Lasers, Inc.
Decision Date2011-09-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers, Inc.. It received FDA 510(k) clearance on 2011-09-13 under 510(k) number K112031. 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 ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION?

ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION is a medical device that received FDA 510(k) clearance on 2011-09-13. The listed applicant is Alma Lasers, Inc.. The 510(k) number is K112031.

When did ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION receive FDA 510(k) clearance?

ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION received FDA 510(k) clearance on 2011-09-13, under 510(k) number K112031.

Who is the listed applicant for ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION?

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

What is the FDA product code for ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION?

The FDA product code for ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION is GEX. This falls under the Gastroenterology category.

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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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