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FDA 510(k)

SPECTRA THERAPY SYSTEM A1000 LASER DEVICE

K-Number: K080689 · 2008-07-09

ApplicantPremier Dynamics, Inc.
Decision Date2008-07-09
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPECTRA THERAPY SYSTEM A1000 LASER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dynamics, Inc.. It received FDA 510(k) clearance on 2008-07-09 under 510(k) number K080689. 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 SPECTRA THERAPY SYSTEM A1000 LASER DEVICE?

SPECTRA THERAPY SYSTEM A1000 LASER DEVICE is a medical device that received FDA 510(k) clearance on 2008-07-09. The listed applicant is Premier Dynamics, Inc.. The 510(k) number is K080689.

When did SPECTRA THERAPY SYSTEM A1000 LASER DEVICE receive FDA 510(k) clearance?

SPECTRA THERAPY SYSTEM A1000 LASER DEVICE received FDA 510(k) clearance on 2008-07-09, under 510(k) number K080689.

Who is the listed applicant for SPECTRA THERAPY SYSTEM A1000 LASER DEVICE?

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

What is the FDA product code for SPECTRA THERAPY SYSTEM A1000 LASER DEVICE?

The FDA product code for SPECTRA THERAPY SYSTEM A1000 LASER DEVICE 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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