Darwin

Luvo Medical Technologies, Inc.

Country / region:Canada (CA)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K212607
Device name
Darwin
Country / region
Canada(CA)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-08-17
Decision date
2021-11-15
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removalPigment treatmentVascular treatmentSkin tightening
Primary application
Hair removal
Classification source
AI classified

Indications for Use

Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.

The IPL handpiece is indicated for:

Indication for Use for the 430-980nm wavelength
* Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
* Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
* For use on Fitzpatrick skin types (I-V)

Indication for use for the 515-980nm wavelength
* Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
* Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
* For use on Fitzpatrick skin types (I-V)

Indication for use for the 560-980nm wavelength
* Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
* Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines.
* The removal of unwanted hair to effect stable long-term or permanent hair reduction.
* For use on Fitzpatrick skin types (I-V)

Indication for use for the 585-980nm wavelength
* Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
* Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
* The removal of unwanted hair to effect stable long-term or permanent hair reduction.
* For use on Fitzpatrick skin types.

Indication for use for the 640-980nm wavelength
* Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae.
* Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte.
* The removal of unwanted hair to effect stable long-term or permanent hair reduction.
* For use on Fitzpatrick skin types (I-V)

Indication for use for the 700-980nm wavelength
* The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
* For use on Fitzpatrick skin types (I-V)

RF Microneedling Handpiece
The RF MicroNeedling Handpiece is indicated for u

Intended Use

Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI) including tanned skin.

Device Description

The Darwin device includes a Diode Laser Handpiece and an IPL Handpiece. The Diode Laser Handpiece operates in hair removal single (HRS) and hair removal moving (HRM) modes. The IPL Handpiece has various filters to create different wavelengths for treating benign pigmented epidermal and cutaneous lesions, benign cutaneous vascular lesions, and for hair removal. The device is designed for use in dermatologic and general surgical procedures.

Summary parsed at:2026-06-01 05:43:44 UTC

Predicate devices

3

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Cited as predicate

0

No later 510(k)s cite this device yet

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