(14 days)
No
The document describes a dental laser system with adjustable parameters, but there is no mention of AI or ML technology being used for image processing, decision-making, or any other function.
Yes.
The device is used for various dental applications for tissue removal, incision, excision, vaporization, ablation, and coagulation, all of which are considered therapeutic actions.
No
The provided text describes a dental laser system used for various treatment procedures such as cavity preparation, caries removal, root canal preparation, bone cutting, and soft tissue ablation. There are no indications or descriptions of the device being used to diagnose conditions.
No
The device description explicitly states it is a "dental laser system" and describes hardware components like a laser, water atomization spray technology, and a flexible fiberoptic handpiece.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical and therapeutic procedures on oral tissues (cavity preparation, caries removal, root canal procedures, bone surgery, soft tissue procedures, periodontal procedures). These are direct interventions on the patient's body.
- Device Description: The device description details a dental laser system that uses laser energy and water spray to cut, remove, roughen, etch, incise, excise, and ablate tissues. This is a physical intervention device.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a surgical/therapeutic dental laser system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device may be used for the following indications (previously cleared under submissions K030523, K071363, and K081589):
General Indications *
- r Class I, II, III, IV and V cavity preparation
- Caries 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
- 이 Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement 트
- l Root canal debridement and cleaning Root Canal Disinfection
- 트 Laser root canal disinfection after endodontic instrumentation Endodontic Surgery (Root Amputation) Indications
- Flap preparation incision of soft tissue to prepare a flap and expose the bone. 트
- Cutting bone to prepare a window access to the apex (apices) of the root(s). l
- Apicoectomy amputation of the root end. 트
- Root end preparation for retrofill amalgam or composite. 트
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 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.
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone) ■
- . Osteotomy
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
- 트 Excisional and incisional biopsies
- I Exposure of unerupted teeth
- I 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)
- I Frenectomy and frenotomy
- Gingival troughing for crown impressions I
- 미 Gingivectomy
- I Gingivoplasty
- I Gingival incision and excision
- 트 Hemostasis
- I Implant recovery
- .. Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical 프 area during apical surgery
- 트 Leukoplakia
- Operculectomy 바
- 트 Oral papillectomies
- l Operculectomy
- Oral papillectomies 트
- 트 Pulpotomy
- Pulp extirpation ■
- 트 Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning 트
- 트 Reduction of gingival hypertrophy
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 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. - Soft tissue crown lengthening ■
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa B
- 트 Vestibuloplasty
-
- For use on adult and pediatric patient Laser Periodontal Procedures
- s Full thickness flap
- l Partial thickness flap
- 트 Split thickness flap
- 트 Laser soft tissue curettage
- 트 Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Removal of highly inflamed edematous tissue affected by bacteria penetration of ■ the pocket lining junctional epithelium
- Removal of granulation tissue from bony defects ■
- Sulcular debridement (removal of diseased, inflamed or necrosed soft I tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Osteoplasty and osseous recontouring (removal of bone to correct osseous defects . and create physiologic osseous contours)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for 프 grafting, etc.)
- . Osseous crown lengthening
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Waterlase C100 dental laser system is a diverse device utilized to perform a variety of dental applications. For hard tissue procedures the Waterlase® C100 uses the Erbium, Chromium, Yttrium, Scandium, Gallium Gamet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er, Cr.YSGG laser energy is applied to incise, excise or ablate these tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues clean.
A flexible fiberoptic handpiece delivers the Waterlase® C100 laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements.
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, root, apex, oral soft tissues, bone, periodontal pocket
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Koq1922
510(k) SPECIAL Summary (As required by 21CFR807.92, 21CFR807.81(a)(3), FDA Memorandum #K97-1)
| Date Prepared: | June 25, 2009
JUL 1 4 2009 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | Biolase Technology, Inc.
4 Cromwell
Irvine, CA 92618
Tel: (949) 361-1200
Fax: (949) 273-6680 |
| Contact: | Ms. Ioana M. Rizoiu
VP, Clinical R&D
Tel: (949) 226-8144
email: irizoiu@biolase.com |
| Trade Name: | Waterlase® C100 |
| Common Name: | Er,Cr:YSGG laser |
| Classification Name: | Surgical laser instrument |
| Classification Code: | 79 GEX, MXF, DZI a Class II device |
| Predicate Devices: | Waterlase®
Biolase Technology, Inc
K030523 (January 30, 2004), K071363 (February 12, 2008)
Waterlase® 3.0
Biolase Technology, Inc |
DEVICE DESCRIPTION:
The Waterlase C100 dental laser system is a diverse device utilized to perform a variety of dental applications. For hard tissue procedures the Waterlase® C100 uses the Erbium, Chromium, Yttrium, Scandium, Gallium Gamet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er, Cr.YSGG laser energy is applied to incise, excise or ablate these tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues clean.
A flexible fiberoptic handpiece delivers the Waterlase® C100 laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements.
1
INDICATIONS FOR USE:
This device may be used for the following indications (previously cleared under submissions K030523, K071363, and K081589):
General Indications *
- r Class I, II, III, IV and V cavity preparation
- Caries 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
- 이 Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement 트
- l Root canal debridement and cleaning Root Canal Disinfection
- 트 Laser root canal disinfection after endodontic instrumentation Endodontic Surgery (Root Amputation) Indications
- Flap preparation incision of soft tissue to prepare a flap and expose the bone. 트
- Cutting bone to prepare a window access to the apex (apices) of the root(s). l
- Apicoectomy amputation of the root end. 트
- Root end preparation for retrofill amalgam or composite. 트
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 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.
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone) ■
- . Osteotomy
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
- 트 Excisional and incisional biopsies
- I Exposure of unerupted teeth
- I 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)
- I Frenectomy and frenotomy
- Gingival troughing for crown impressions I
- 미 Gingivectomy
- I Gingivoplasty
- I Gingival incision and excision
- 트 Hemostasis
- I Implant recovery
2
- .. Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical 프 area during apical surgery
- 트 Leukoplakia
- Operculectomy 바
- 트 Oral papillectomies
- l Operculectomy
- Oral papillectomies 트
- 트 Pulpotomy
- Pulp extirpation ■
- 트 Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning 트
- 트 Reduction of gingival hypertrophy
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 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.
- Soft tissue crown lengthening ■
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa B
- 트 Vestibuloplasty
-
- For use on adult and pediatric patient Laser Periodontal Procedures
- s Full thickness flap
- l Partial thickness flap
- 트 Split thickness flap
- 트 Laser soft tissue curettage
- 트 Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Removal of highly inflamed edematous tissue affected by bacteria penetration of ■ the pocket lining junctional epithelium
- Removal of granulation tissue from bony defects ■
- Sulcular debridement (removal of diseased, inflamed or necrosed soft I tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
- Osteoplasty and osseous recontouring (removal of bone to correct osseous defects . and create physiologic osseous contours)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for 프 grafting, etc.)
- . Osseous crown lengthening
CONTRAINDICATIONS:
All clinical procedures performed with the Waterlase® C100 must be subject to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general
3
medical conditions, which might contraindicate a local procedure. Such conditions may include, but are not limited to, allergy to local or topical anesthetics, heart disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from the patient's physician is advisable when doubt exists regarding treatment.
CONCLUSION:
The indications included herein are the same as indications that have been previously cleared by the FDA for the predicate device. Substantial equivalency for the Waterlase C100 has been determined through comparison to previously cleared devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of several thick, curved lines that create the shape of the bird's body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolase Technology, Inc. % Ms. Ioana M. Rizoiu VP, Clinical R & D 4 Cromwell Irvine, California 92618
JUL 1 4 2009
Re: K091922
Trade/Device Name: Waterclase® C100 Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Product Code: GEX Dated: June 25, 2009 Received: June 30, 2009
Dear Mr. Rizoiu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Ms. Ioana M. Rizoiu
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801); please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Mark N.Melkerson
Director
Division of Surgical, Orthopedic
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: Waterlase® C100
Indications for Use:
General Indications *
- 지 Class I, II, III, IV and V cavity preparation
- I Caries removal
- 트 Hard tissue surface roughening or etching
- 트 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 트
- Root canal debridement and cleaning ■
Root Canal Disinfection
- I Laser root canal disinfection after endodontic instrumentation
Endodontic Surgery (Root Amputation) Indications
- li 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). I
- 내 Apicoectomy - amputation of the root end.
- 보 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
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- Osteotomy
sseous tissues (bone)
Neil R. Oden for m
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091922
7
Laser Periodontal Procedures
- Full thickness flap 트
- Partial thickness flap 트
- 트 Split thickness flap
- Laser soft tissue curettage 트
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal l pocket
- Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining 피 and junctional epithelium
- Removal of granulation tissue from bony defects 트
- 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)
- . Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
- Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.) 트
- 미 Osseous crown lengthening
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
- Excisional and incisional biopsies I
- I Exposure of unerupted teeth
- E Fibroma removal
- I 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 치 impactions)
- l Frenectomy and frenotomy
- Gingival troughing for crown impressions 1
- I Gingivectomy
- 1 Gingivoplasty
- Gingival incision and excision i
- 1 Hemostasis
- Implant recovery 프
- Incision and drainage of abscesses 트
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during 트 apical surgery
- Leukoplakia . B
- Operculectomy 비
- 트 Operculectomy
Neil R.P. Oside by mka
(Division Sign-Off)
Division of Surgical. Orthopedic. and Restorative Devices
510(k) Number K091922
8
- Oral papillectomies
- Pulpotomy
- Pulp extirpation I
- Pulpotomy as an adjunct to root canal therapy I
- Root canal debridement and cleaning K
- I Reduction of gingival hypertrophy
- Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues I (i.e., granulation tissue) from around the apex
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) nust be submitted to a qualified laboratory for histopathological evaluation.
- Soft tissue crown lengthening 트
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa 트
- 트 Vestibuloplasty
-
- For use on adult and pediatric patient
Prescription Use _ X Use
AND/OR
Over-the-Counter
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MulRedde Forman
Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091922