(42 days)
No
The summary describes a dental diode laser for various oral soft tissue procedures and teeth whitening. There is no mention of AI, ML, image processing, or any data-driven algorithms in the device description, intended use, or performance studies.
Yes
The device is described as a "Dental diode laser" used for various dental and oral soft tissue procedures, including excision, ablation, and hemostasis, which are therapeutic interventions.
No
The device is described as a "Dental diode laser" used for various surgical procedures, such as incision, excision, ablation, and hemostasis, as well as for teeth whitening. Its intended uses are interventional and therapeutic, not diagnostic.
No
The device description explicitly states "Dental diode laser," which is a hardware device. The intended use also describes procedures performed with a laser, not software.
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 intended use and device description clearly indicate that this is a dental diode laser used for surgical procedures on oral soft tissue and for teeth whitening. It directly interacts with the patient's body for treatment and modification, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LVI lase is intended for incision, excision, ablation, vaporization, and/or coagulation of oral soft tissue (including marginal and interdental gingival and epithelial lining of free gingiva). It is also intended for light activation for bleaching materials for teeth whitening, and laser-assisted bleaching/whitening for teeth whitening.
For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.
Examples:
Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Frenectomy and frenotomy
Gingival troughing for crown impressions
Gingivectomy
Gingivoplasty
Gingival incision and excision
Hemostasis
Implant recovery
Incision and drainage of abscess
Leukoplakia
Operculectomy
Oral papillectomies
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
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)
Treatment of aphthous ulcers
Vestibuloplasty
Biopsy incision and excision
Lesion (tumor) removal
For light activation for bleaching materials for teeth whitening
For laser-assisted bleaching/whitening for teeth.
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 soft tissue
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)
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
AUG = 5 2004
9. 510(k) Summary
| 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: | LVI lase |
| Common Name: | Dental diode laser |
| Classification Name:
Classification Code: | Instrument, surgical, powered, laser
79-GEX |
| Equivalent Device(s): | DioDent Dental Laser System by HOYA ConBio,
Aurora by Premier Laser System,
Twilite or Dentek LD-15 Diode Laser System by BioLase
Technologies,
DioLase ST by American Medical Technology (formerly ADT) |
| Intended Use: | The LVI lase is intended for incision,
excision, ablation, vaporization, and/or coagulation of oral soft
tissue (including marginal and interdental gingival and epithelial
lining of free gingiva). It is also intended for light activation for
bleaching materials for teeth whitening, and laser-assisted
bleaching/whitening for teeth whitening. |
| Comparison: | The LVI lase, the DioDent Dental Laser
System, the Aurora Diode Laser System, the
Twilite/Dentek LD-15, the Dental Diode Laser, and the DioLase
ST are equivalent in operating parameters, physical characteristics,
and intended uses. (NOTE: Of the equivalent devices mentioned
here, only the DioDent and the Twilite are cleared for teeth
whitening intended uses. The LVI lase is seeking clearance for
this in this submission). |
| Nonclinical Performance
Data: | None |
| Clinical Performance Data: | None |
| Additional Information: | None |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUN 1 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HOYA ConBio, Inc. % Liza Burns and Associates Ms. Liza Burns Regulatory Consultant 19722 Westview Drive Twain Harte, California 95383
Re: K041721
Trade/Device Name: LVI lase Dental Diode Laser Regulation Number: 21 CFR 878.4800 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 21, 2004 Received: June 29, 2004
Dear Ms. Burns
This letter corrects our substantially equivalent letter of August 5, 2004.
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 (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); good manufacturing practice requirements as set
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Page 2 - Ms. Liza Burns
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 continue 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkers
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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1. Indications for Use Statement
| 510(k) Number: | K041721 |
|---|---|
| Device Name: | LVI lase |
| Indications for Use: | For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue. |
| Examples: | |
| Excisional and incisional biopsies | |
| Exposure of unerupted teeth | |
| Fibroma removal | |
| Frenectomy and frenotomy | |
| Gingival troughing for crown impressions | |
| Gingivectomy | |
| Gingivoplasty | |
| Gingival incision and excision | |
| Hemostasis | |
| Implant recovery | |
| Incision and drainage of abscess | |
| Leukoplakia | |
| Operculectomy | |
| Oral papillectomies | |
| Pulpotomy | |
| Pulpotomy as an adjunct to root canal therapy | |
| Reduction of gingival hypertrophy | |
| Soft tissue crown lengthening | |
| 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) | |
| Treatment of aphthous ulcers | |
| Vestibuloplasty | |
| Biopsy incision and excision | |
| Lesion (tumor) removal |
For light activation for bleaching materials for teeth whitening
For laser-assisted bleaching/whitening for teeth. |
| (Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number: | K041721 |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart D)
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OR
Over-the-Counter Use_ (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)