# K150664: NeoLas

- Pathway: 510(k) (Traditional)
- Applicant: Sheaumann Laser, Inc.
- Decided: Dec 22, 2015 after 281 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: 12 generations back to K910422 (1992). 129 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120377: Adverl Evo ER: Yag Laser for Dentistry Mey-1-a, J. Morita USA, Inc. (2012) Summary page 6.
- K102359: Picasso/ Picasso Lite/ Picasso Perio, Amd Lasers, LLC (2011) Summary page 6.

## Most influential descendants
- K254197: Picasso Pro Diode Laser (002-00460) (2026), 0 descendants of its own

## Indications for use
The NeoLas Er:YAG laser. and its accessories, are intended for use in dentistry, dermatology and other surgical areas in the following procedures: In dentistry for: Endodontic Surgery (Root Amputation) Indications: * Root end preparation for retrofill amalgam or composite * Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex. NOTE: Any tissue growth (i.e. cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation Laser Periodontal Procedures: » Full thickness flap » Partial thickness flap » Split thickness flap » Laser soft tissue curettage * Laser removal of diseased, infected. inflamed and necrosed soft tissue within the periodontal pocket * Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium * Removal of granulation tissue from bony defects * Sulcular debridement (removal of diseased, infected, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) The NeoLas 810nm Soft Tissue laser and its accessories are intended for use on adult and pediatric patients in dentistry, dermatology and other surgical areas in the following procedures: Soft Tissue Indications including Pulpal Tissues* Incision, excision, vaporization, ablation and coagulation or oral soft tissues, including: * Excisional and incisional biopsies * Exposure of unerupted teeth * Fibroma removal * Flap preparation—incision of soft tissue to prepare a flap and expose the bone. * Flap preparation—incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) * Frenectomy and frenotomy * Gingival troughing for crown impressions * Gingivectomy * Gingivoplasty * Gingival incision and excision » Hemostasis and coagulation * Implant recovery » Incision and drainage of abscesses * Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery * Leukoplakia * Operculectomy * Oral papillectomies * Pulpotomy » Pulp extirpation * Pulpotomy as an adjunct to root canal therapy » Reduction of gingival hypertrophy * Removal of pathological tissues (i.e. cyst, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex * Root canal debridement and cleaning » Soft tissue crown lengthening * Treatment of canker sores, herpetic and aphthous ulcer of the oral mucosa * Vestibuloplasty NOTE: Any tissue growth (i.e. cyst. neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation

Source page: https://510kreport.com/device/K150664
Methodology: https://510kreport.com/methodology