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FDA 510(k)

CELL GEN LASER, MODEL CG-4000

K-Number: K080084 · 2008-04-21

ApplicantCell Gen Therapeutics, LLC
Decision Date2008-04-21
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CELL GEN LASER, MODEL CG-4000 is the device name listed in this FDA 510(k) record. The listed applicant is Cell Gen Therapeutics, LLC. It received FDA 510(k) clearance on 2008-04-21 under 510(k) number K080084. 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 CELL GEN LASER, MODEL CG-4000?

CELL GEN LASER, MODEL CG-4000 is a medical device that received FDA 510(k) clearance on 2008-04-21. The listed applicant is Cell Gen Therapeutics, LLC. The 510(k) number is K080084.

When did CELL GEN LASER, MODEL CG-4000 receive FDA 510(k) clearance?

CELL GEN LASER, MODEL CG-4000 received FDA 510(k) clearance on 2008-04-21, under 510(k) number K080084.

Who is the listed applicant for CELL GEN LASER, MODEL CG-4000?

The FDA 510(k) record lists Cell Gen Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELL GEN LASER, MODEL CG-4000?

The FDA product code for CELL GEN LASER, MODEL CG-4000 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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