(232 days)
Not Found
No
The summary describes a dental laser system with adjustable power and pulse settings, but there is no mention of AI or ML technology being used for image processing, data analysis, or automated decision-making. The device description focuses on the laser technology and its delivery system.
Yes
The device is described with applications for treating various dental and oral health conditions, including incision, excision, vaporization, and ablation of oral soft tissues, as well as periodontal procedures and treatment of canker sores, which are therapeutic interventions.
No
The device description and intended use/indications for use specify actions like incision, excision, vaporization, ablation, and coagulation of tissues, and tooth whitening. These are all therapeutic or procedural actions, not diagnostic ones. There is no mention of the device being used to identify or analyze diseases or conditions.
No
The device description explicitly states it is a "dental diode laser system" and describes hardware components like a "Gallium Aluminum Arsenide (GaAlAs) solid state laser diode" and a "flexible fiberoptic handpiece." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The LaserSmile™ dental diode laser system is a therapeutic and procedural device. It uses laser energy to perform surgical procedures on oral soft tissues and to activate bleaching materials for teeth whitening. It directly interacts with the patient's body and tissues.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It applies energy to the body.
- Intended Use: The intended uses listed are all direct treatments or procedures performed on the patient's oral cavity.
Therefore, the LaserSmile™ device falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dental Soft Tissue Indications for: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakja Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulccrs of the oral mucosa. Vestibuloplasty. Laser Periodontal procedures, including: 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 and junctional epithelium Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.). Tooth Whitening Indications: Laser assisted whitening/bleaching of teeth. Light activation for bleaching materials for teeth whitening.
Product codes (comma separated list FDA assigned to the subject device)
79 GEX, GEX
Device Description
The LaserSmile™ dental diode laser system may be used to perform several dental applications. LaserSmile™ uses advanced laser technology to incise, excise and ablate intraoral soft tissues and to activate a bleaching material for whitening/bleaching teeth safely and effectively. A Gallium Aluminum Arsenide (GaAlAs) solid state laser diode provides optical energy to oral soft tissues and tooth bleaching compounds. A flexible fiberoptic handpiece delivers the LaserSmile™ laser energy. A visible light emitted from the handpicce distal end pinpoints the area of treatment. The optical power output and pulse may be adjusted to specific user requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral soft tissues, periodontal pocket, teeth.
Indicated Patient Age Range
Not Found
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.
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.
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OCT 1 0 2003
030539
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510(k) Summary of Safety and Effectiveness Information
| 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: | LaserSmileTM |
| Common Name: | Dental diode laser |
| Classification Name: | Surgical laser instrument |
| Classification Code: | 79 GEX |
| Equivalent Devices: | |
| | BioLase Technology, Inc. Waterlase® |
| | BioLase Technology, Inc. TwiliteTM |
Device Description:
The LaserSmile™ dental diode laser system may be used to perform several dental applications. LaserSmile™ uses advanced laser technology to incise, excise and ablate intraoral soft tissues and to activate a bleaching material for whitening/bleaching teeth safely and effectively. A Gallium Aluminum Arsenide (GaAlAs) solid state laser diode provides optical energy to oral soft tissues and tooth bleaching compounds.
A flexible fiberoptic handpiece delivers the LaserSmile™ laser energy. A visible light emitted from the handpicce distal end pinpoints the area of treatment. The optical power output and pulse may be adjusted to specific user requirements.
U
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630539 2/3
Indications for Use:
Dental Soft Tissue Indications for:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakja Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulccrs of the oral mucosa. Vestibuloplasty
Laser Periodontal procedures, including:
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 and junctional epithelium Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
Tooth Whitening Indications:
Laser assisted whitening/bleaching of teeth. Light activation for bleaching materials for teeth whitening.
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030539 7/3
Contraindications:
All clinical procedures performed with LaserSmile™ 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 that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.
Patients with periodontal disease and/or exposed root surfaces are not candidates for laser tooth bleaching/whitening. Also, patients with damaged or fissured enamel are not candidates for laser bleaching/whitening.
Substantial Equivalence:
There are no unique applications, indications, materials or specifications presented herein. All the submitted indications for use retain the same meaning as their equivalent indications cleared by the FDA in K991994 (Twilite™, original indications for use), and in K011041 (Waterlase®, expanded indications for use).
Conclusion:
LaserSmile™ is substantially equivalent to dental products previously cleared for marketing. LaserSmile™ performs the same indications for use through the same mechanism as the other cleared devices. Evidence of equivalence has been demonstrated through the following:
- . Equivalent performance specification
- Equivalent intended use ●
- Feature comparison table ●
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
OCT 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ioana M. Rizoiu Vice President, Clinical Research and Development BioLase Technology, Inc. 981 Calle Amanecer San Clemente, CA 92673
Re: K030539
Trade/Device Name: LaserSmile™ Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: July 11, 2003 Received: July 16, 2003
Dear Ms. 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 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Daryl Wisdahl
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,
Miriam C. Provost
feCelia 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
5
510(k) Number (if known): K030539
LaserSmile™ Device Name:
Indications for Use:
Dental Soft Tissue Indications for:
Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including:
Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coaqulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of qinqival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa Vestibuloplasty
Laser Periodontal procedures, including:
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 Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K630539
6
.
,
Tooth whitening procedures, including:
Light activation for bleaching materials for teeth whitening. Laser-assisted whitening/bleaching of teeth.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
or
| Over-The-Counter-Use | |
|---|---|
| ---------------------- | -- |
| Miriam C. Provost | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices |
| 510(k) Number | K030539 |
|---|---|
| --------------- | --------- |