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FDA 510(k)

SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL

K-Number: K962109 · 1997-03-13

ApplicantClassy Lady by Mehl of Puerto Rico, Inc.
Decision Date1997-03-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL is the device name listed in this FDA 510(k) record. The listed applicant is Classy Lady by Mehl of Puerto Rico, Inc.. It received FDA 510(k) clearance on 1997-03-13 under 510(k) number K962109. 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 SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL?

SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL is a medical device that received FDA 510(k) clearance on 1997-03-13. The listed applicant is Classy Lady by Mehl of Puerto Rico, Inc.. The 510(k) number is K962109.

When did SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL receive FDA 510(k) clearance?

SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL received FDA 510(k) clearance on 1997-03-13, under 510(k) number K962109.

Who is the listed applicant for SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL?

The FDA 510(k) record lists Classy Lady by Mehl of Puerto Rico, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL?

The FDA product code for SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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