FDA 510(k)

LASE SYSTEM II

K-Number: K853927 · 1985-10-16

ApplicantJames L. Geraci & Associates, Inc.

Decision Date1985-10-16

Product Code

DecisionSubstantially Equivalent

Device Summary

LASE SYSTEM II is the device name listed in this FDA 510(k) record. The listed applicant is James L. Geraci & Associates, Inc.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K853927. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASE SYSTEM II?

LASE SYSTEM II is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is James L. Geraci & Associates, Inc.. The 510(k) number is K853927.

When did LASE SYSTEM II receive FDA 510(k) clearance?

LASE SYSTEM II received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853927.

Who is the listed applicant for LASE SYSTEM II?

The FDA 510(k) record lists James L. Geraci & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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.