NeoLas

Sheaumann Laser, Inc.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K150664
Device name
NeoLas
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-03-16
Decision date
2015-12-22
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

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. cysts, 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

Intended 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. 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. cysts, 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 ti

Device Description

NeoLas is a portable, microprocessor controlled dual laser system with both ER:YAG and Soft Tissue capabilities. The NeoLas provides treatment capabilities via two separate fiber jumper and handpiece assemblies; NeoLas1 (ER:YAG) and NeoLas2 (Soft Tissue). The NeoLas1 treatment delivery system emits a 2.94um infrared photon pulses that are used in the treatment of various endodontic and soft tissue indications. The NeoLas2 treatment delivery system utilizes solid-state diode laser (GaAlAs) technology to emit constant wavelength and pulsed energy of 808nm to perform soft tissue treatments.

Summary parsed at:2026-06-01 06:11:02 UTC

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