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FDA 510(k)

LUX1540, LUX1440 & LUX2940 LASER HANDPIECES

K-Number: K101506 · 2010-09-01

ApplicantPalomar Medical Technologies, Inc.
Decision Date2010-09-01
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUX1540, LUX1440 & LUX2940 LASER HANDPIECES is the device name listed in this FDA 510(k) record. The listed applicant is Palomar Medical Technologies, Inc.. It received FDA 510(k) clearance on 2010-09-01 under 510(k) number K101506. 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 LUX1540, LUX1440 & LUX2940 LASER HANDPIECES?

LUX1540, LUX1440 & LUX2940 LASER HANDPIECES is a medical device that received FDA 510(k) clearance on 2010-09-01. The listed applicant is Palomar Medical Technologies, Inc.. The 510(k) number is K101506.

When did LUX1540, LUX1440 & LUX2940 LASER HANDPIECES receive FDA 510(k) clearance?

LUX1540, LUX1440 & LUX2940 LASER HANDPIECES received FDA 510(k) clearance on 2010-09-01, under 510(k) number K101506.

Who is the listed applicant for LUX1540, LUX1440 & LUX2940 LASER HANDPIECES?

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

What is the FDA product code for LUX1540, LUX1440 & LUX2940 LASER HANDPIECES?

The FDA product code for LUX1540, LUX1440 & LUX2940 LASER HANDPIECES is ONG.

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Other records listing Palomar Medical Technologies, 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.

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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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