# K212607: Darwin

- Pathway: 510(k) (Traditional)
- Applicant: Luvo Medical Technologies, Inc.
- Decided: Nov 15, 2021 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K943450 (1995). 582 ancestors in all.
No later device cites it as a predicate yet.
0 of 583 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203728: Darwin, Luvo Medical Technologies, Inc. (2021) Summary page 5.
- K210129: RF Thermal System, Luvo Medical Technologies, Inc. (2021) Summary page 5.

## Indications for use
The Diode Laser Handpiece is indicated for: 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. The IPL Handpiece has various filters to create different wavelengths. The various wavelengths are broken down by wavelength and applicable indication 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 use in dermatologic and general surgical procedures for electro-coagulation and hemostasis Thermal RF Handpiece The Thermal RF Handpiece is indicated for heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

Source page: https://510kreport.com/device/K212607
Methodology: https://510kreport.com/methodology