# K031828: Naturalase LP ND:Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Focus Medical, LLC
- Decided: Jul 17, 2003 after 34 days
- Product code: GEN (Forceps, General & Plastic Surgery)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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). 92 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 1.
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models, Altus Medical, Inc. (2002) Summary page 1.
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models, Altus Medical, Inc. (2002) Summary page 1.
- K003202: Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II, Altus Medical (2001). Our reading of the summary gave K003203, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Family of Altus CoolGlide Aesthetic Lasers”.
- K003147: Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration), Laserscope (2000) Summary page 1.
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002) Summary page 1.
- K010834: Lyra Series Surgical Laser System & Accessories, Laserscope (2001) Summary page 1.
- K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (1999) Summary page 1.
- K020107: Smartepil, Cynosure, Inc. (2002). Our reading of the summary gave K020197, FDA’s number for Modification to Datacaptor (Capsule Technologie). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cynosure Smartepil”.

## Most influential descendants
- K041829: Focus Medical Naturalase LP and Naturalight Family of Products (2004), 4 descendants of its own
- K081219: Apollo Mini Ipl System (2008), 3 descendants of its own
- K110304: Apex ER. Yag / Ipl System (2011), 2 descendants of its own
- K123777: Multilaser System (2013), 1 descendant of its own
- K233143: PiXel8-Reveal (2024), 0 descendants of its own

## Indications for use
The Focus Medical NaturaLase LP Laser is indicated for: General Surgical Applications: Incision, excision, coagulation, hemostasis, vaporization, and/or ablation of soft tissue in dermatology/plastic surgery, endoscopicllaparoscopic general surgery, gastroenterology, general surgery, gynecology, head and neck/ otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary surgery, thoracic surgery, and urology. Dermatology/Plastic Surgery: Coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lake, leg and spider veins. In addition, the NaturaLase LP is intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or bluehlack tattoos) and plaques. The NaturaLase LP Laser is also 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. Cutting, incision, excision, hemostasis, coagulation, vaporization and ablation of soft tissue in dermatology and plastic surgery. The NaturaLase LP Laser is also indicated for the treatment of facial wrinkles and wrinkles such as, but not limited to, periocular and periorbital wrinkles. The NaturaLase LP Laser is indicated for the removal of unwanted hair, for the stable long tem, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The NaturaLase LP iaser is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The NaturaLase LP Laser is indicated for use on all skin types (Fitzpatrick [ - IV) including tanned skin. EndoscopidLaparoscopic Surgery: The NaturaLase LP Laser is also indicated for use in a variety of surgical procedures in several surgical specialties. These include, but not limited to, cholecystectomy, appendectomy, vagotomy, and pyloromyomotomy where its abilities to incise, excise, coagulate, vaporize, or ablate soft tissue may be applied. Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstruction including squamous cell carcinoma and adenocarcinoma, gastrointestinal hemostasis including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions, gastroiritestinal tissue ablation including benign and malignant neoplasm, angiodysplasia, polyp:j, ulcer, colitis, and hemorrhoids. General Surgery: Incision, excision, vaporization, ablation, and hemostasis of soft tissue general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, tonsillectomy, and hemorrhoids. Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the: uterus, ablation of endometrial implants and/or peritoneal adhesions, soft tissue excisional procedures such as excisional conization of the cervix, intrauterine ‘gyncwlogic procedures where cutting, ablation, and/or vessel coagulation may be indicated including submucous fibroids, benign endometrial polyps, and uterine septum. Head and NecWOtorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis. Hemostasis During Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures. Neurosurgery: Hemostasis for pituitary tumor, meningioma, hemagioblastoma, AVMs. glioblastoma, astrocytoma, oligodendroglioma. Oculoplastics: Incision, excision, vaporization, and/or coagulation of tissues in oculoplastic procedures such as operations on the lacrimal system, operation on the eyelids, removal of bi'opsy or orbital tumors, enucleation on eyeball, exteneration of orbital contents. Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications. PuImonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, benign tumors, granulomas, and benign strictures. Thoracic Surgery: Cutting (incisiodexcision), coagulating, and vaporization of soft tissue. Thoracic applications including, but not limited to, isolation of vessels for endarterectomy and/or by-pass grafts, wedge resections, thoractomy, formation of pacemaker pockets; vaporizatron, coagtflation, incisiodexcision, debulking, and ablation of lung tissue (thoracoscopy). Urology: All applications including superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures and lesions of the external genitdia (including condyloma acuminata).

Source page: https://510kreport.com/device/K031828
Methodology: https://510kreport.com/methodology