Manufacturer
Sheaumann Laser, Inc.NeoLas
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K150664
- Device name
- NeoLas
- Company
- Sheaumann Laser, Inc.
- 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
Predicate devices
3Cited as predicate
1Picasso Pro Diode Laser (002-00460)
1 submission cite K150664 as a predicate
