Manufacturer
Luvo Medical Technologies, Inc.Darwin
Luvo Medical Technologies, Inc.
Country / Region:Canada (CA)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
3Spirit Hair Removal laser Family
Darwin
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Not ingested
K212607 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K212607 as a predicate
