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Light Tree Ventures Europe B.V.

11 FDA records filed under this company name, from 2022 to 2026, in light for wrinkles (OHS, 7), hair growth (OAP, 3), light for acne (OLP, 1).

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.

LED and light devices for wrinkles (OHS, 7)

510(k) cleared

myLEDmask 2 (MJ-144)

510(k) number
K260415
Applicant
Light Tree Ventures Europe B.V.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

Infrared Heat (Model: E0221)

510(k) number
K223893
Applicant
Light Tree Ventures Europe B.V.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

Q-Rejuvalight Pro Facewear (Model: P19-0023)

510(k) number
K230042
Applicant
Light Tree Ventures Europe B.V.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Q-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)

510(k) number
K230124
Applicant
Light Tree Ventures Europe B.V.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)

510(k) number
K221775
Applicant
Light Tree Ventures Europe B.V.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“For MK-78, MK-04, The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles. For MK66-H, EL00003 The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

LED Eye Perfector, model: EY-36A, EY-36B

510(k) number
K221444
Applicant
Light Tree Ventures Europe B.V.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

LED Light Therapy Mask (model: MK66R-B)

510(k) number
K221946
Applicant
Light Tree Ventures Europe B.V.
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP, 3)

510(k) cleared

Hair Regrowth Cap (Model: T-119-HRC)

510(k) number
K253349
Applicant
Light Tree Ventures Europe B.V.
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“Hair Regrowth Cap is indicated to treat Androgenetic Alopecia and promote hair growth in males who have NorwoodHamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.”

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

510(k) cleared

Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)

510(k) number
K230597
Applicant
Light Tree Ventures Europe B.V.
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)

510(k) number
K230336
Applicant
Light Tree Ventures Europe B.V.
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

LED and light devices for acne (OLP, 1)

510(k) cleared

LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001

510(k) number
K230720
Applicant
Light Tree Ventures Europe B.V.
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001, PR5001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.