(41 days)
DELight Dental Er: YAG Laser System, WaterLase, Millennium Dental Laser System, Premier Centauri Dental Laser System
Not Found
No
The provided text describes a dental laser system and its various intended uses and indications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies sections.
Yes
The VersaWave Dental Er:YAG Laser System is indicated for various medical procedures, including cavity preparation, bone cutting, removal of pathological tissues, and treatment of canker sores, which are all therapeutic interventions aimed at treating or alleviating medical conditions.
No
The VersaWave Dental Er:YAG Laser System is indicated for various surgical and treatment procedures on hard and soft tissues in the oral cavity, such as cavity preparation, root canal treatment, bone cutting, periodontal procedures, and incision/excision of soft tissues. It describes therapeutic interventions rather than diagnostic functions like detecting or identifying diseases.
No
The device is described as a "VersaWave Dental Er:YAG Laser System" and its intended uses involve physical actions on hard and soft tissues using a laser. This clearly indicates a hardware component (the laser system) is integral to the device's function, not just software.
Based on the provided information, the VersaWave Dental Er:YAG Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- VersaWave's Intended Use: The VersaWave Dental Er:YAG Laser System is intended for various dental procedures performed directly on the patient's tissues (hard tissue, root canal, bone, soft tissue). These procedures involve cutting, shaping, removing, and treating tissues within the oral cavity.
- Lack of Specimen Analysis: The provided information does not mention the device being used to analyze any specimens taken from the patient. While it mentions submitting tissue growth for histopathological evaluation, this evaluation would be performed by a separate laboratory, not by the VersaWave device itself.
Therefore, the VersaWave Dental Er:YAG Laser System is a therapeutic and surgical device used for direct treatment of oral tissues, not an IVD device used for in vitro analysis of specimens.
N/A
Intended Use / Indications for Use
The VersaWave Dental Er:YAG Laser System is intended for
Hard Tissue General Indications*
- Class I, II, III, IV and V cavity preparation .
- Carries removal .
- Hard tissue surface roughening or etching .
- Enameloplasty, excavation of pits and fissures for placement of sealants .
*For use on adult and pediatric patients
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal .
- Root canal preparation including enlargement .
- Root canal debridement and cleaning .
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal ●
- Root canal preparation including enlargement .
- Root canal debridement and cleaning .
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone) .
- . Osteotomy
Endodontic Surgery (Root Amputation) Indications
- Flap preparation incision of soft tissue to prepare a flap and expose the bone .
- Cutting bone to prepare a window access to the apex (apices) of the root(s). .
- Apicoectomy amputation of the root end. .
- Root end preparation for retrofill amalgam or composite .
- Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic . Removal of pathological nesues (rom around the apex. Note: Any tissue growth (i.e. tissues (1.6. grandiaren besions) 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 son ubsed of our and of the . periodontal pocket
- perfouontal pother
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, 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)
- gingi rai otooming masti, master, many of bone to correct osseous defects and . create physiological osseous contours)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for . grafting, etc.)
- Osseous crown lengthening .
Soft Tissue Indications Including Pulpal Tissues*
Incision, excision, vaporization, ablation, and coagulation of 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 the 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 .
- Incision and drainage of periapical 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, abscess) and hyperplastic . tissues (i.e. granulation tissue). Note: any tissue growth (i.e., cyst, neoplasm or other tissues (f.c. grandration aboratory for histopathological evaluation.
- Root canal debridement and cleaning .
- Soft tissue crown lengthening .
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa .
- Vestibuloplaty .
*For use on adult and pediatric patients
Product codes
79-GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral osseous tissues (bone), root canal, periodontal pocket, oral soft tissues, teeth
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DELight Dental Er: YAG Laser System, WaterLase, Millennium Dental Laser System, Premier Centauri Dental Laser System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
K041710 1/3
9. 510(k) Summary
AUG - 3 2004
| Company: | HOYA ConBio (formerly Continuum Electro-Optics, Inc.)
47733 Fremont Blvd
Fremont, CA 94538
(800) 532-1064 phone
(510) 445-4550 fax |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jim Green
Vice President of Engineering |
| Device Trade Name: | VersaWave Dental Er:YAG Laser System |
| Common Name: | Medical Laser System |
| Classification Name:
Classification Code: | Instrument, surgical, powered, laser
79-GEX |
| Equivalent Device(s): | DELight Dental Er: YAG Laser System
WaterLase, Millennium Dental Laser System
Premier Centauri Dental Laser System |
| Intended Use: | The VersaWave Dental Er:YAG Laser System is intended for |
Hard Tissue General Indications*
- Class I, II, III, IV and V cavity preparation .
- Carries removal .
- Hard tissue surface roughening or etching .
- Enameloplasty, excavation of pits and fissures for placement of sealants .
*For use on adult and pediatric patients
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal .
- Root canal preparation including enlargement .
- Root canal debridement and cleaning .
Root Canal Hard Tissue Indications
- Tooth preparation to obtain access to root canal ●
- Root canal preparation including enlargement .
- Root canal debridement and cleaning .
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone) .
- . Osteotomy
Endodontic Surgery (Root Amputation) Indications
- Flap preparation incision of soft tissue to prepare a flap and expose the bone .
1
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\zeta \circ \mathcal{A} \ne \emptyset$$
- Cutting bone to prepare a window access to the apex (apices) of the root(s). .
- Apicoectomy amputation of the root end. .
- Root end preparation for retrofill amalgam or composite .
- Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic . Removal of pathological nesues (rom around the apex. Note: Any tissue growth (i.e. tissues (1.6. grandiaren besions) 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 son ubsed of our and of the . periodontal pocket
- perfouontal pother
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, 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)
- gingi rai otooming masti, master, many of bone to correct osseous defects and . create physiological osseous contours)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for . grafting, etc.)
- Osseous crown lengthening .
Soft Tissue Indications Including Pulpal Tissues*
Incision, excision, vaporization, ablation, and coagulation of 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 the 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 .
- Incision and drainage of periapical abscesses .
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area . during apical surgery
2
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