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FDA 510(k)

MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE

K-Number: K091446 · 2009-10-27

ApplicantPalomar Medical Products, Inc.
Decision Date2009-10-27
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Palomar Medical Products, Inc.. It received FDA 510(k) clearance on 2009-10-27 under 510(k) number K091446. 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 MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE?

MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE is a medical device that received FDA 510(k) clearance on 2009-10-27. The listed applicant is Palomar Medical Products, Inc.. The 510(k) number is K091446.

When did MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE receive FDA 510(k) clearance?

MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE received FDA 510(k) clearance on 2009-10-27, under 510(k) number K091446.

Who is the listed applicant for MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE?

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

What is the FDA product code for MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE?

The FDA product code for MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE is ONG.

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Other records listing Palomar Medical Products, 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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