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FDA 510(k)

iHelmet Laser Comb

K-Number: K202631 · 2020-12-08

Decision Date2020-12-08
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

iHelmet Laser Comb is the device name listed in this FDA 510(k) record. The listed applicant is Slinph Technologies Co., Ltd.. It received FDA 510(k) clearance on 2020-12-08 under 510(k) number K202631. 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 iHelmet Laser Comb?

iHelmet Laser Comb is a medical device that received FDA 510(k) clearance on 2020-12-08. The listed applicant is Slinph Technologies Co., Ltd.. The 510(k) number is K202631.

When did iHelmet Laser Comb receive FDA 510(k) clearance?

iHelmet Laser Comb received FDA 510(k) clearance on 2020-12-08, under 510(k) number K202631.

Who is the listed applicant for iHelmet Laser Comb?

The FDA 510(k) record lists Slinph Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iHelmet Laser Comb?

The FDA product code for iHelmet Laser Comb is OAP.

Other records listing Slinph Technologies Co., Ltd. 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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