(16 days)
No
The device description explicitly states that the only changes are minor software and graphics changes that do not affect the operational software, and there is no mention of AI or ML in the document.
Yes
The device's intended uses, such as cavity preparation, caries removal, root canal treatment, various surgical procedures, and treatment of pathological tissues, are all therapeutic in nature, aiming to treat or alleviate dental and oral health conditions.
No
The device description and intended use/indications for use only describe procedures for treatment, such as cavity preparation, caries removal, root canal preparation, incision, excision, and removal of tissues. There is no mention of the device being used to identify, detect, or diagnose a condition or disease.
No
The device description explicitly states it is a dental laser device with hardware components (Waterlase MD laser system, Turbo handpiece). The software changes are minor additions to the control panel of this hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed indications are all related to surgical and therapeutic procedures performed directly on the patient's oral tissues (hard and soft tissue, bone, root canals). IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a dental laser system used for various dental procedures. This aligns with a therapeutic or surgical device, not a diagnostic one that analyzes samples.
- No mention of analyzing biological samples: There is no mention of the device being used to test or analyze any biological specimens from the patient.
- No mention of diagnostic information: The intended uses are focused on treating conditions and performing procedures, not on providing diagnostic information based on sample analysis.
Therefore, the Waterlase MD with the Turbo handpiece, as described, is a dental laser device used for surgical and therapeutic interventions, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
General Indications
- 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
- Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement
- Root canal debridement and cleaning
Root Canal Disinfection
- Laser root canal disinfection after endodontic treatment
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 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:
- 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
- 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
- Operculectomy
- Oral papillectomies
- Pulpotomy
- Pulp extirpation
- Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning
- 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
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
- Vestibuloplasty
- For use on adult and pediatric patient
Laser Periodontal Procedures
- Full thickness flap
- Partial thickness flap
- Split thickness flap
- Laser soft tissue curettage
- 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 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.)
- Osseous crown lengthening
Product codes
GEX
Device Description
The Waterlase MD is a dental laser device previously cleared by the FDA for hard and soft tissue dental indications (K031140, K071363). The only changes from the previously cleared device are the addition of the Turbo handpiece, which combines minor software and graphics changes that will be added to the Waterlase MD laser system. This software does not change the operational software, but adds a "Select" icon on the control panel, and unassigned pre-sets fields for use by the dentist to store preferred setting selections. There are no other hardware or software changes to the Waterlase MD device pending herein when compared to the device cleared under K031140 and K071363.
Materials used for the Turbo handpiece are the same as those for the MD Gold handpiece. Biocompatibility testing of these materials was conducted in compliance with 21 CFR Part 820, Quality System Regulation, Subpart C, Sec. 820.30 - Design Controls, and ISO 13485-2003, Section 7.3 - Design and Development; documented results (on file) confirmed there is no biocompatibility risk presented by these materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral soft tissues, Oral osseous tissues (bone), Root canal, Periodontal pocket, Periapical area, Gingival, Teeth, Apex (apices) of the root(s)
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KOGOLFI
Special 510k Summary of Safety and Effectiveness Waterlase® MD New Accessor Biolase Technology, Inc January 23, 2009
FER = 1 2009
Special 510(k) Summary of Safety and Effectiveness Information
Regulatory Authority:
CONFIDENTIAL :
Company:
Contact:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Biolase Technology, Inc. 4 Cromwell Irvine, CA 92618
Ms. Ioana M. Rizoiu Biolase Technology, Inc. 4 Cromwell Irvine, CA 92618 Tel: (949) 226-8144 Fax: (949) 273-6680
Trade Name:
Waterlase® MD
Common Name:
Er, Cr: YSGG laser
Classification Name:
Classification Code:
Surgical laser instrument 79 GEX, a Class II device
Equivalent Devices:
Waterlase® MD Biolase Technology, Inc. K031140, July 7, 2004
Device Description:
The Waterlase MD is a dental laser device previously cleared by the FDA for hard and soft tissue dental indications (K031140, K071363). The only changes from the previously cleared device are the addition of the Turbo handpiece, which combines minor software and graphics changes that will be added to the Waterlase MD laser system. This software does not change the operational software, but adds a "Select" icon on the control panel, and unassigned pre-sets fields for use by the dentist to store preferred setting selections. There are no other hardware or software changes to the Waterlase MD device pending herein when compared to the device cleared under K031140 and K071363.
Materials used for the Turbo handpiece are the same as those for the MD Gold handpiece. Biocompatibility testing of these materials was conducted in compliance with 21 CFR Part 820, Quality System Regulation, Subpart C, Sec. 820.30 - Design Controls, and ISO 13485-2003, Section 7.3 - Design and Development; documented results (on file) confirmed there is no biocompatibility risk presented by these materials.
1
Indications for Use:
General Indications *
- I Class I, II, III, IV and V cavity preparation
- I Caries removal
- 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 ■
- 트 Root canal preparation including enlargement
- 지 Root canal debridement and cleaning
Root Canal Disinfection
- 트 Laser root canal disinfection after endodontic treatment
Endodontic Surgery (Root Amputation) Indications
- 트 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).
- 1 Apicoectomy - amputation of the root end.
- 요 Root end preparation for retrofill amalgam or composite.
- . Removal of pathelogical 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
- 트 Cutting, shaving, contouring and resection of oral osseous tissues (bone)
- 비 Osteotomy
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
- 보 Excisional and incisional biopsies
- . Exposure of unerupted teeth
- l Fibroma removal
- 트 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 트
- Gingival troughing for crown impressions 피
- B Gingivectomy
- Gingivoplasty 트
2
CONFIDENTIAL
- Gingival incision and excision
- Hemostasis
- 트 implant recovery
- I Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during 트 apical surgery
- 파 Leukoplakia
- . Operculectomy
- I Oral papillectomies
- Operculectomy
- 1 Oral papillectomies
- 에 Pulpotomy
- Pulp extirpation
- 8 Pulpotomy as an adjunct to root canal therapy
- D Root canal debridement and cleaning
- 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
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
- Treatment of cariker sores, herpetic and aphthous ulcers of the oral mucosa ■
- Vestibuloplasty
-
- For use on adult and pediatric patient
Laser Periodontal Procedures
- Full thickness flap
- 제 Partial thickness flap
- Split thickness flap
- 트 Laser soft tissue curettage
- . Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- 제 Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining
- 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 bleedingindex, probe depth, attachment loss and tooth mobility)
- 제 Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours)
- 요 Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
- 트 Osseous crown lengthening
3
All Contraindications remain the same as for the previously cleared device, Waterlase®MD (K031140)
Contraindications:
All clinical procedures performed with the Waterlase®MD must be subjected 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 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 the indications that have been previously cleared by the FDA for the Waterlase®MD (K031140, K071363). Substantial equivalency for the Waterlase MD with the Turbo Handpiece has been determined through comparison to the previously cleared Waterlase MD.
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 stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2009
Biolase Technology, Inc. % Ms. Ioana Rizoiu VP, Clinical Research & Development 4 Cromwell Irvine, California 92618
Re: K090181
Trade/Device Name: Waterlase MD (Turbo Handpiece) 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: January 23, 2009 Received: January 26, 2009
Dear Mr. Christensen:
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. Ilisting 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 such 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); good manufacturing practice requirements as set
5
Page 2 - Ms. Ioana Rizoiu
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
Mark N. Mulhausen
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: Waterlase MD (Turbo Handpiece)
Indications for Use:
General Indications *
- Class I, II, III, IV and V cavity preparation .
- Caries removal 에
- 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
- B Tooth preparation to obtain access to root canal
- Root canal preparation including enlargement
- Root canal debridement and cleaning M
Root Canal Disinfection
- Laser root canal disinfection after endodontic treatment 에
Endodontic Surgery (Root Amputation) Indications
- 트 Flap preparation = incision of soft tissue to prepare a flap and expose the bone.
- 지 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 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 (bor
- Osteotomy
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft assussion
- Excisional and incisional biopsies
- Exposure of unerupted teeth
Division of General, Restorative, and Neurological Devices
510(k) Number_
7
- 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 피 impactions)
- Frenectomy and frenotomy
- Gingival troughing for crown impressions 트
- 트 Gingivectomy
- 이 Gingivoplasty
- 해 Gingival incision and excision
- 트 Hemostasis
- 지 implant recovery
- 트 Incision and drainage of abscesses
- Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during ■ apical surgery
- 을 Leukoplakia
- l Operculectomy
- Oral papillectomies
- Operculectomy
- Oral papillectomies
- Pulpotomy
- Pulp extirpation
- Pulpotomy as an adjunct to root canal therapy
- Root canal debridement and cleaning
- Reduction of gingival hypertrophy
-
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
- I Soft tissue crown lengthening
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa ■
- I Vestibuloplastv
- For use on adult and pediatric patient .
Laser Periodontal Procedures
- Full thickness flap
- Partial thickness flap I
- Split thickness flap
- Laser soft tissue curettage
l mucosa
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K090181
- 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 I junctional epithelium
junct to root canal
ement and cleaning
- Removal of pathelegical tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues
(i.e., granulation tissue) from around the apex
(i.e., granulation tissue) from around the apex
TE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted
8
- 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)
- Osteoplasty and esseous 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.)
- Osseous crown lengthening
Prescription Use X Use (Part 21 CFR 801 Subpart D) Over-the-Counter
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K090181 510(k) Number