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FDA 510(k)

SMARTEPIL,DEPILASE YAG LASE PLUS

K-Number: K112141 · 2012-04-13

ApplicantCastle Laser Systems, Limited
Decision Date2012-04-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMARTEPIL,DEPILASE YAG LASE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Castle Laser Systems, Limited. It received FDA 510(k) clearance on 2012-04-13 under 510(k) number K112141. 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 SMARTEPIL,DEPILASE YAG LASE PLUS?

SMARTEPIL,DEPILASE YAG LASE PLUS is a medical device that received FDA 510(k) clearance on 2012-04-13. The listed applicant is Castle Laser Systems, Limited. The 510(k) number is K112141.

When did SMARTEPIL,DEPILASE YAG LASE PLUS receive FDA 510(k) clearance?

SMARTEPIL,DEPILASE YAG LASE PLUS received FDA 510(k) clearance on 2012-04-13, under 510(k) number K112141.

Who is the listed applicant for SMARTEPIL,DEPILASE YAG LASE PLUS?

The FDA 510(k) record lists Castle Laser Systems, Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTEPIL,DEPILASE YAG LASE PLUS?

The FDA product code for SMARTEPIL,DEPILASE YAG LASE PLUS 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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