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Shenzhen Mlay Intelligent Technology Co., , Ltd.

4 FDA records filed under this company name, from 2024 to 2026, in hair removal (OHT, 4).

Also filed with slightly different spelling: “Shenzhen Mlay Intelligent Technology Co., Ltd.”. We group names that differ only in capitals, spacing or punctuation.

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

Laser and IPL hair removal (mostly over-the-counter; 1 record says prescription use) (OHT, 4)

510(k) cleared

IPL Hair Removal Device (Models: T31A, T32A)

510(k) number
K253666
Applicant
Shenzhen Mlay Intelligent Technology Co., Ltd.
Product code
OHT: Light Based Over-The-Counter Hair Removal
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)

510(k) number
K251176
Applicant
Shenzhen Mlay Intelligent Technology Co., , Ltd.
Product code
OHT: Light Based Over-The-Counter Hair Removal
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The IPL Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)

510(k) number
K241106
Applicant
Shenzhen Mlay Intelligent Technology Co., , Ltd.
Product code
OHT: Light Based Over-The-Counter Hair Removal
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Ice Cooling IPL Home Use Hair Removal Device is an over-the-counter device indicated for the removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs. The device is also indicated for the permanent reduction in hair regrowth, defined as the long term, stable reduction in the amount of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.

510(k) cleared

Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)

510(k) number
K240264
Applicant
Shenzhen Mlay Intelligent Technology Co., , Ltd.
Product code
OHT: Light Based Over-The-Counter Hair Removal
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Home use hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, in patients with Fitzpatrick Skin Phototypes I-V.”

Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.