# K140122: Candela Gentlemax Family of Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: May 9, 2014 after 113 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: 11 generations back to K910422 (1992). 138 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122493: Genesisplus, Cutera, Inc. (2013) Summary page 1.
- K133283: Candela Gentlemax Family of Laser Systems, Candela Corp. (2013) Summary page 1.

## Most influential descendants
- K201111: GentleMax Pro Plus (2020), 3 descendants of its own
- K200110: SANDRO Dual (2020), 2 descendants of its own
- K183452: Vbeam Prima Laser System (2019), 1 descendant of its own
- K161632: FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) (2016), 1 descendant of its own
- K253828: Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) (2026), 0 descendants of its own

## Indications for use
The GentleMAX Family of Laser Systems is indicated for the following at the specified wavelength: 755nm Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias) 1064nm Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. 1064nm Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.)

Source page: https://510kreport.com/device/K140122
Methodology: https://510kreport.com/methodology