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FDA 510(k)

NEUROLASE, MODELS 150V, 150C, 1064

K-Number: K032787 · 2003-11-20

ApplicantSpectrum Laser & Technologies
Decision Date2003-11-20
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEUROLASE, MODELS 150V, 150C, 1064 is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Laser & Technologies. It received FDA 510(k) clearance on 2003-11-20 under 510(k) number K032787. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROLASE, MODELS 150V, 150C, 1064?

NEUROLASE, MODELS 150V, 150C, 1064 is a medical device that received FDA 510(k) clearance on 2003-11-20. The listed applicant is Spectrum Laser & Technologies. The 510(k) number is K032787.

When did NEUROLASE, MODELS 150V, 150C, 1064 receive FDA 510(k) clearance?

NEUROLASE, MODELS 150V, 150C, 1064 received FDA 510(k) clearance on 2003-11-20, under 510(k) number K032787.

Who is the listed applicant for NEUROLASE, MODELS 150V, 150C, 1064?

The FDA 510(k) record lists Spectrum Laser & Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROLASE, MODELS 150V, 150C, 1064?

The FDA product code for NEUROLASE, MODELS 150V, 150C, 1064 is ILY.

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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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