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FDA 510(k)

CURAE'LASE CL1000 IR LASER SYSTEM

K-Number: K053201 · 2005-12-09

ApplicantCurae'Lase, Inc.
Decision Date2005-12-09
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CURAE'LASE CL1000 IR LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Curae'Lase, Inc.. It received FDA 510(k) clearance on 2005-12-09 under 510(k) number K053201. 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 CURAE'LASE CL1000 IR LASER SYSTEM?

CURAE'LASE CL1000 IR LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-09. The listed applicant is Curae'Lase, Inc.. The 510(k) number is K053201.

When did CURAE'LASE CL1000 IR LASER SYSTEM receive FDA 510(k) clearance?

CURAE'LASE CL1000 IR LASER SYSTEM received FDA 510(k) clearance on 2005-12-09, under 510(k) number K053201.

Who is the listed applicant for CURAE'LASE CL1000 IR LASER SYSTEM?

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

What is the FDA product code for CURAE'LASE CL1000 IR LASER SYSTEM?

The FDA product code for CURAE'LASE CL1000 IR LASER SYSTEM is ILY.

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Related Devices (Code: ILY)

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Official Source

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