# K193072: Lucent : IPL

- Pathway: 510(k) (Traditional)
- Applicant: Luvo Medical Technologies, Inc.
- Decided: Mar 5, 2020 after 122 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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: 19 generations back to K910422 (1992). 342 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 346 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 5.
- K142860: Lumenis M22 System, Lumenis, Ltd. (2015) Summary page 5.

## Most influential descendants
- K203728: Darwin (2021), 1 descendant of its own
- K240314: Mula (K2-A1) (2024), 0 descendants of its own
- K212607: Darwin (2021), 0 descendants of its own

## Indications for use
The Lucent : IPL is Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. 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 (I-V) 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)

Source page: https://510kreport.com/device/K193072
Methodology: https://510kreport.com/methodology