# K222790: F65 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis Be, Ltd.
- Decided: Jun 14, 2023 after 272 days
- Product code: OAP (Laser, Comb, Hair)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K910422 (1992). 324 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 328 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193500: Stellar M22 for Intense Pulsed Light (IPL) and Laser System, Lumenis, Ltd. (2020) Summary page 5.

## Most influential descendants
- K252723: Dynamis Pro Family (2026), 0 descendants of its own
- K261821: 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) (2026), 0 descendants of its own
- K242349: FoLix (2024), 0 descendants of its own

## Indications for use
The subject F65 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for: o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles) o Cutaneous lesions, including warts, scars and striae o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles o Mild to moderate inflammatory Acne (Acne vulgaris) The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for: o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles o The non-ablative treatment of facial wrinkles The F65 module and handpiece, with wavelength of 1565 nm, are indicated for: o Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue o Improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss. The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: o Removal of dark tattoos o Treatment of pigmented lesions *Note Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

Source page: https://510kreport.com/device/K222790
Methodology: https://510kreport.com/methodology