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FDA 510(k)

RESURFX 1565NM LASER MODULE

K-Number: K130028 · 2013-09-03

ApplicantLumenis, Ltd.
Decision Date2013-09-03
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESURFX 1565NM LASER MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2013-09-03 under 510(k) number K130028. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESURFX 1565NM LASER MODULE?

RESURFX 1565NM LASER MODULE is a medical device that received FDA 510(k) clearance on 2013-09-03. The listed applicant is Lumenis, Ltd.. The 510(k) number is K130028.

When did RESURFX 1565NM LASER MODULE receive FDA 510(k) clearance?

RESURFX 1565NM LASER MODULE received FDA 510(k) clearance on 2013-09-03, under 510(k) number K130028.

Who is the listed applicant for RESURFX 1565NM LASER MODULE?

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

What is the FDA product code for RESURFX 1565NM LASER MODULE?

The FDA product code for RESURFX 1565NM LASER MODULE is ONG.

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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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