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FDA 510(k)

Laser Hair Therapy

K-Number: K183329 · 2019-01-16

Decision Date2019-01-16
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Laser Hair Therapy is the device name listed in this FDA 510(k) record. The listed applicant is Omm Imports, Inc. D/B/A Zero Gravity. It received FDA 510(k) clearance on 2019-01-16 under 510(k) number K183329. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Laser Hair Therapy?

Laser Hair Therapy is a medical device that received FDA 510(k) clearance on 2019-01-16. The listed applicant is Omm Imports, Inc. D/B/A Zero Gravity. The 510(k) number is K183329.

When did Laser Hair Therapy receive FDA 510(k) clearance?

Laser Hair Therapy received FDA 510(k) clearance on 2019-01-16, under 510(k) number K183329.

Who is the listed applicant for Laser Hair Therapy?

The FDA 510(k) record lists Omm Imports, Inc. D/B/A Zero Gravity as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laser Hair Therapy?

The FDA product code for Laser Hair Therapy is OAP.

Other records listing Omm Imports, Inc. D/B/A Zero Gravity as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: OAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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