# K153671: Family of CoolGlide Aesthetic Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Mar 9, 2016 after 79 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: 21 generations back to K943450 (1995). 544 ancestors in all.
32 later devices descend from it; 6 cite it directly.
0 of 577 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132185: Family of Coolglide Aesthetic Lasers, Cutera, Inc. (2013) Summary page 5.
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 5.
- K120235: Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo, Lightpod ND: Yag Lasers, Lightp, Aerolase Medical Lasers, LLC (2012) Summary page 5.
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro, Fotona D.D. (2015) Summary page 5.

## Most influential descendants
- K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (2017), 24 descendants of its own
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (2018), 22 descendants of its own
- K222064: The Alma Soprano Titanium (2022), 14 descendants of its own
- K183156: V-Laser (2019), 3 descendants of its own
- K251329: Diode laser device (RF3120-BI) (2025), 2 descendants of its own

## Indications for use
The Cutera Family of CoolGlide Aesthetic Lasers is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 755 nm: The Family of CoolGlide Aesthetic Lasers is indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime. The Family of CoolGlide Aesthetic Lasers is also indicated for: • treatment of benign pigmented lesions • treatment of wrinkles • photocoagulation of dermatological vascular lesions, such as, but not limited to, port wine stains, hemangiomas and telangiectasias 1064 nm: Dermatology: The Family of CoolGlide Aesthetic Lasers is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques. Additionally, the lasers are 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. The CoolGlide lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles. The CoolGlide lasers are indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime. The CoolGlide lasers are also indicated for the treatment for pseudofolliculitis barbae (PFB). The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The lasers are also indicated for treatment of mild to moderate inflammatory acne vulgaris. The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The intended use of the integral cooling system in the CoolGlide laser handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments. Surgical Applications: The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia), and urology. 532 nm: For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size). Optional Pulsed Light Handpiece: For the treatment of benign pigmented lesions.

Source page: https://510kreport.com/device/K153671
Methodology: https://510kreport.com/methodology