(89 days)
Not Found
Not Found
No
The summary describes a light/laser activation device for teeth whitening and does not mention any AI/ML terms, image processing, or performance studies related to algorithmic analysis.
No
The device is used for teeth whitening, which is a cosmetic procedure and not a therapeutic one that treats a disease or condition.
No
The device is described as being used for "Light activation for bleaching materials for teeth whitening" and "Laser-assisted bleaching/whitening for teeth," which are therapeutic or cosmetic procedures, not diagnostic ones. There is no mention of identifying, detecting, or monitoring any condition.
No
The intended use and predicate devices clearly indicate a hardware device (light/laser activation for bleaching materials). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Light activation for bleaching materials for teeth whitening. Laser-assisted bleaching/whitening for teeth." This describes a procedure performed directly on the patient's teeth, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Anatomical Site: The anatomical site is "Teeth," which are part of the patient's body, not a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
The device appears to be a light or laser device used to activate bleaching agents applied to teeth, which is a therapeutic or cosmetic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Light activation for bleaching materials for teeth whitening. Laser-assisted bleaching/whitening for teeth.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-Clinical Performance Data: None. Clinical Performance Data: None.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
510(k) Summary
| K022351 | |
|---|---|
| Submitted by: | Continuum Electro-Optics, Inc. |
| 3150 Central Expressway | |
| Santa Clara, CA 95051 | |
| (408) 727-3340 - Phone | |
| (408) 727-3550 - FAX | |
| Contact: | Thomas J. Haney |
| Manager, Dental Products | |
| Date Summary Prepared: | July 17, 2002 |
| Device Trade Name: | DioDent Dental Laser System |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, Surgical, Powered, Laser |
| Equivalent Device(s): | TwiLite/TwiLiteWhite |
| by Biolase Technology, Inc. | |
| Ceralas Model D15 | |
| by Ceramoptec, Inc. | |
| Opus 10 | |
| by OpusDent, Inc. | |
| Intended Use: | Teeth Whitening |
| Comparison: | Principles of operation, function and |
| intended use for the DioDent, | |
| TwiLite/TwiLiteWhite, Ceralas Model D15 | |
| and Opus 10 laser systems are identical. | |
| Non-Clinical Performance Data: | None. |
| Clinical Performance Data: | None. |
| Additional Information: | None. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
OCT 1 6 2002
Continuum Electro-Optics, Inc. Thomas J. Haney Manager, Dental Products 3150 Central Expressway Santa Clara, California 95051
Re: K022351
Trade/Device Name: DioDent Dental Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: July 17, 2002 Received: July19, 2002
Dear Mr. Haney:
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. Iisting 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 mav 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 setforth 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.
2
Page 2 – Mr. Thomas J. Haney:
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Atyt Qurch
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
3
510(k) Number (if known): .
0223)1
Indications for Use:
.
Light activation for bleaching materials for teeth whitening. Laser-assisted bleaching/whitening for teeth.
(Do Not Write Below this Line. Continue on Another Page if Needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Styp Rhode
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number | C 022351
Perscription Use:
(Per 21 CFR 801.109)
✓
Over-The-Counter Use: (Optional Format 1-2-96)
CO0083