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FDA 510(k)

IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03

K-Number: K223524 · 2023-02-16

ApplicantMorlaser Shenzhen Co., Ltd.
Decision Date2023-02-16
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 is a medical device manufactured by Morlaser Shenzhen Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under approval number K223524. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03?

IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 is a medical device that received FDA 510(k) clearance on 2023-02-16. It is manufactured by Morlaser Shenzhen Co., Ltd.. The 510(k) number is K223524.

When was IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 approved by the FDA?

IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 received FDA 510(k) clearance on 2023-02-16, under approval number K223524.

What company makes IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03?

IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 is manufactured by Morlaser Shenzhen Co., Ltd..

What is the FDA product code for IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03?

The FDA product code for IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 is OHT.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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