(42 days)
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.
Dental diode laser
The provided 510(k) summary for the LVI lase dental diode laser states that no clinical or non-clinical performance data was submitted.
Therefore, the device's acceptance criteria and the study proving it meets these criteria are not detailed in the provided text. The submission was likely based on demonstrating substantial equivalence to predicate devices, focusing on operating parameters, physical characteristics, and intended uses rather than novel performance claims requiring extensive new testing.
The document explicitly states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
Without specific studies mentioned, it's impossible to provide the requested details regarding:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
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AUG = 5 2004
9. 510(k) Summary
| Company: | HOYA ConBio (formerly Continuum Electro-Optics, Inc.)47733 Fremont BlvdFremont, CA 94538(800) 532-1064 phone(510) 445-4550 fax |
|---|---|
| Contact: | Jim GreenVice President of Engineering |
| Device Trade Name: | LVI lase |
| Common Name: | Dental diode laser |
| Classification Name:Classification Code: | Instrument, surgical, powered, laser79-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 BioLaseTechnologies,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 softtissue (including marginal and interdental gingival and epitheliallining of free gingiva). It is also intended for light activation forbleaching materials for teeth whitening, and laser-assistedbleaching/whitening for teeth whitening. |
| Comparison: | The LVI lase, the DioDent Dental LaserSystem, the Aurora Diode Laser System, theTwilite/Dentek LD-15, the Dental Diode Laser, and the DioLaseST are equivalent in operating parameters, physical characteristics,and intended uses. (NOTE: Of the equivalent devices mentionedhere, only the DioDent and the Twilite are cleared for teethwhitening intended uses. The LVI lase is seeking clearance forthis in this submission). |
| Nonclinical PerformanceData: | None |
| Clinical Performance Data: | None |
| Additional Information: | None |
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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 biopsiesExposure of unerupted teethFibroma removalFrenectomy and frenotomyGingival troughing for crown impressionsGingivectomyGingivoplastyGingival incision and excisionHemostasisImplant recoveryIncision and drainage of abscessLeukoplakiaOperculectomyOral papillectomiesPulpotomyPulpotomy as an adjunct to root canal therapyReduction of gingival hypertrophySoft tissue crown lengtheningSulcular 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 ulcersVestibuloplastyBiopsy incision and excisionLesion (tumor) removalFor light activation for bleaching materials for teeth whiteningFor laser-assisted bleaching/whitening for teeth. |
| (Division Sign-Off)Division of General, Restorative,and Neurological Devices510(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)
§ 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.