# K033251: The Friendlylight ND: Yag Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Innotech USA, Inc.
- Decided: Mar 2, 2004 after 147 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: 7 generations back to K910422 (1992). 87 ancestors in all.
519 later devices descend from it; 2 cite it directly.
0 of 607 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models, Altus Medical, Inc. (2002) Summary page 1.
- K023967: Palomar Q-Yag ND:Yag Laser System, Palomar Medical Technologies, Inc. (2003) Summary page 1.
- K010104: Candela Long Pulse ND:Yag, Candela Corp. (2001) Summary page 1.
- K022951: Candela Gentle Yag Laser System, Variable Pulse Yag, Candela Corp. (2003) Summary page 1.
- K970808: Medlite IV Q-Switched, Frequency Doubled, ND:Yag Laser, Continuum Biomedical, Inc. (1997) Summary page 1.
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 1.
- K010316: Cooltouch Varia ND:Yag Laser System; Cooltouch Varia-II ND:Yag Laser System, Cooltouch Corp. (2001) Summary page 1.
- K001704: ATHOS, Cosmos Medical Technology (2000) Summary page 3.
- K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (1999) Summary page 2.
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002) Summary page 2.
- K012552: Sciton Image Hair Removal Laser, Sciton, Inc (2001) Summary page 2.

## Most influential descendants
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own

## Indications for use
The FriendlyLight® Nd:YAG lasers are intended to be used in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroentermology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculaplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: The FriendlyLight® Nd:YAG Laser systems are intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as 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), cafr 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 FriendlyLight® Nd:YAG lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkldes. The FriendlyLight® Nd:YAG lasers are also indicated for the removal of unwanted hair, for stable long termn, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The FriendlyLight® Nd:YAG 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 FriendlyLight® Nd:YAG lasers are indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin. Surgical Application: The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy gastroenterology, general surgery, head and neck/otorhiniolaryngology (ENT) neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary! thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Source page: https://510kreport.com/device/K033251
Methodology: https://510kreport.com/methodology