(345 days)
Not Found
No
The summary describes a laser system for dental procedures and does not mention any AI or ML capabilities.
Yes
The device, Waterlase, is described with numerous indications for use in dental and oral procedures, which include treatment of diseases, injuries, or conditions (e.g., caries removal, root canal debridement, removal of pathological tissues, treatment of canker sores, etc.), and thus falls under the definition of a therapeutic device.
No
The Waterlase system is described for various dental and surgical applications, including cavity preparation, caries removal, root canal procedures, bone cutting, and soft tissue incisions, all of which are treatment-oriented rather than diagnostic. The device description also focuses on its function as a laser system for cutting, removing, roughening, etching, incising, excising, and ablating tissues.
No
The device description clearly describes a hardware system including a laser, water atomization technology, a fiberoptic handpiece, and adjustable physical parameters (power output, pulse energy, repetition rate, air and water flow rates). This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 about a person's health. This testing is done outside of the body (in vitro).
- Waterlase Function: The Waterlase device is a laser system used to directly treat tissues within the patient's mouth. It cuts, removes, roughens, etches, incises, excises, vaporizes, ablates, and coagulates tissues. It is a therapeutic and surgical device, not a diagnostic one.
- Intended Use: The listed intended uses all involve direct intervention on the patient's tissues for treatment purposes (cavity preparation, root canal procedures, bone surgery, periodontal procedures, soft tissue procedures).
- Device Description: The description details how the laser energy is used to interact with tissues, not how it analyzes samples.
While the device description mentions that "Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation," this refers to a separate diagnostic process performed after the Waterlase is used for tissue removal. The Waterlase itself is not performing the diagnostic evaluation.
N/A
Intended Use / Indications for Use
Hard Tissue
.
(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 .
Bone Surgical Indications
.
- Cutting, shaving, contouring and resection of oral osseous tissucs (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 tissues (i.e., granulation tissue) from around the apcx. 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 discased, infected, inflamed and necrosed soft tissue t the provinsity of the first of the first the first the first the first the first the first the first the first the first the finitial was and the finalisting the finalism of the fini within the periodontal pocket
- Removal of highly inflamed edematous tissuc affected by bacteria . penetration of the pocket lining and junctional epithelium
- Removal of granulation tissue from bony defects .
- Sulcular debridement (removal of diseased, inflamcd 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
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 이 unerupted teeth (hard and soft tissue impactions)
- Frenectomy and frenotomy .
- Gingival troughing for crown impressions *
- Gingivectomy *
- Gingivoplasty ◆
- Gingival incision and excision ◆
- Hemostasis& coagulation
- s 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 or abscess) and . hyperplastic tissues (i.e. granulation tissue). Note: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
- Root canal debridement and cleaning .
- Soft tissue crown lengthening .
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa ◆
- . Vestibuloplasty
- For use on adult and pediatric patients
Product codes (comma separated list FDA assigned to the subject device)
GEX, MXF, DZI
Device Description
The Waterlase hydrokinetic dental laser system is a diverse device utilized to perform a variety of dental applications. For hard tissue procedures the Waterlase uses the Erbium, Chromium: Yttrium, Scandium, Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization 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 the tissues clean.
A flexible fiberoptic handpiece delivers the Waterlase laser e nergy. 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 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 tissucs (bone), root canal, apex (apices) of the root(s), soft tissue, periodontal pocket, bony defects, oral soft tissues, unerupted teeth, gingival, gingival troughing, post-extraction tooth sockets, periapical area, oral mucosa
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.
K011041, K012511, K013908, K022803
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.
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
030523 1/4
| | 510(k) Summary of Safety
and Effectiveness Information | JAN 30 2004 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Regulatory
Authority: | Safe Medical Devices Act of 1990,
21 CFR 807.92 | |
| Company: | BioLase Technology, Inc.
981 Calle Amanecer
San Clemente, CA 92673 | |
| Contact: | Ms. Ioana M. Rizoiu
BioLase Technology, Inc.
981 Calle Amanecer
San Clemente, CA 92673
(949) 361-1200 (949) 361-0204 Fax | |
| Trade Name: | Waterlase® | |
| Common Name: | Er,Cr:YSGG laser | |
| Classification Name: | Surgical laser instrument | |
| Classification Code: | 79 GEX, MXF, DZI | |
| Equivalent Devices: | | |
| BioLase Technology, Inc. | Waterlase® | |
Device Description:
The Waterlase hydrokinetic dental laser system is a diverse device utilized to perform a variety of dental applications. For hard tissue procedures the Waterlase uses the Erbium, Chromium: Yttrium, Scandium, Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization 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 the tissues clean.
A flexible fiberoptic handpiece delivers the Waterlase laser e nergy. 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 and air and water flow rates are adjustable to specific user requirements.
1
Indications for Use:
Hard Tissue
.
(General Indications*
-
Class I, II, III, IV and V cavity preparation
2/4 -
. 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 .
Bone Surgical Indications
.
- Cutting, shaving, contouring and resection of oral osseous tissucs (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 tissues (i.e., granulation tissue) from around the apcx. 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 discased, infected, inflamed and necrosed soft tissue t the provinsity of the first of the first the first the first the first the first the first the first the first the finitial was and the finalisting the finalism of the fini within the periodontal pocket
- Removal of highly inflamed edematous tissuc affected by bacteria . penetration of the pocket lining and junctional epithelium
- Removal of granulation tissue from bony defects .
- Sulcular debridement (removal of diseased, inflamcd 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)
2
030523 3/4
WaterLase™ Expanded Indications for Use BioLase Technology, Inc. October 29, 2003
- 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
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 이 unerupted teeth (hard and soft tissue impactions)
- Frenectomy and frenotomy .
- Gingival troughing for crown impressions *
- Gingivectomy *
- Gingivoplasty ◆
- Gingival incision and excision ◆
- Hemostasis& coagulation �
- s 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 or abscess) and . hyperplastic tissues (i.e. granulation tissue). Note: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation.
- Root canal debridement and cleaning .
- Soft tissue crown lengthening .
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa ◆
- . Vestibuloplasty
- For use on adult and pediatric patients
Cautions and Contraindications:
All clinical procedures performed with Waterlase must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always
3
030513 4/4
WaterLase™ Expanded Indications for Use BioLase Technology, Inc. October 29, 2003
be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercisc caution for gencral medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart discase, lung disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.
Substantial Equivalence:
There are no unique applications, indications, materials or specifications presented herein. All the presented indications for use retain the same meaning as their equivalent indications cleared by the FDA in K011041 (Waterlase", expanded soft tissue indications including Sulcular Debridement), K012511 (Waterlase " indications for Root Canal), K013908 (Waterlase , indications for oral osseous procedures) and K022803 (Waterlase , indications for Endodontic Surgery).
Conclusion:
The indications included herein are the same as those included in previous clearances. Waterlase is therefore substantially equivalent in relation to the previous clearances.
4
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 a stylized symbol that resembles an abstract caduceus, featuring three parallel lines that curve and converge.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2004
Ms. Ioana M. Rizoiu Vice President, Clinical Research and Development Biolase Technology, Inc. 981 Calle Amanecer San Clemente, California 92673
Re: K030523 Trade/Device Name: Waterlase® Regulation Number: 21 CFR 878.4810 Regulation Name: Lascr surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Codc: GEX Dated: October 31, 2003 Received: November 3, 2003
Dear Ms. Rizoiu:
We have reviewed your Scction 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 adultcration.
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 Codc 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 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 -
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K030523
Device Name: Waterlase®
Indications for Use:
Use of Waterlase may be indicated for:
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
Endodontic Surgery (Root Amputation) Indications (soft and hard tissue)
- 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). 후
- 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 8 tissues (i.e., granulation tissue) from around the apex
- I Incision and drainage of periapical abscesses
- 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
Laser Periodontal Procedures
- . Full thickness flap
- . Partial thickness flap
- . Split thickness flap
- . Laser soft tissue curettage
Mark A. Milken
Neurological Devices
7
-
- 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 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)
- . 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.)
- t Osseous crown lengthening
Soft Tissue Indications Including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, includina:
- 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 so area during apical surgery
- Leukoplakia .
- Operculectomy
- . Oral papillectomies
- . Pulpotomy
- . Pulp extirpation
- Pulpotomy as an adjunct to root canal therapy
- 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
-
Reduction of gingival hypertrophy
8
- Soft tissue crown lengthening .
- Treatment of canker sores, herpetic and aphthous uicers of the oral mucosa •
- . Vestibuloplasty
-
- For use on adult and pediatric patients
-
for Mark A. Mellers
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________