(56 days)
WaterLase, Millennium dental laser system
D220023, K152528
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology. The intended use and predicate devices suggest a traditional dental laser system.
Yes
The device is used for tooth preparation, pulpotomy, pulp extirpation, and root canal procedures, which are all therapeutic interventions for dental conditions.
No
The device's intended uses, such as tooth preparation, pulpotomy, pulp extirpation, root canal debridement, cleaning, and preparation, describe therapeutic or procedural actions rather than diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description is not available, but the intended use and predicate device (a dental laser system) strongly suggest a hardware-based device for dental procedures, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to direct treatment and manipulation of the tooth and root canal. These are clinical procedures performed on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The intended uses described here do not involve the analysis of such specimens.
- Device Description: While the device description is "Not Found," the intended uses clearly point to a device used for surgical or therapeutic procedures within the mouth.
- Other Information: The lack of mentions of image processing, AI/ML, input imaging modality, and performance studies related to diagnostic metrics further supports that this is not an IVD.
The listed predicate device, "WaterLase, Millennium dental laser system," also aligns with devices used for dental procedures, not IVD testing.
N/A
Intended Use / Indications for Use
- Tooth preparation to obtain access to the root canal 1.
-
- Pulpotomy
-
- Pulp extirpation
-
- Pulpotomy as an adjunct to root canal therapy
-
- Root canal debridement and cleaning
-
- Root canal preparation including enlargement
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
Not Found
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
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
Not Found
Predicate Device(s)
WaterLase, Millennium dental laser system
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
21616
510(k) Summary
JUL 1 1 2002
| Submitter: | Continuum Electro-Optics, Inc.
3150 Central expressway
Santa Clara, CA 95051 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tom Haney
Manager, Dental Products |
| Date Summary Prepared: | May 14, 2002 |
| Device Trade Name: | DELight dental laser system |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX |
| Equivalent Device(s): | WaterLase, Millennium dental laser system |
| Intended Use: | a) Tooth preparation to obtain access to the root canal
b) Pulpotomy
c) Pulp extirpation
d) Pulpotomy as an adjunct to root canal therapy
e) Root canal debridement and cleaning
f) Root canal preparation including enlargement |
| Comparison: | The BioLase WaterLase, Millennium dental laser system are
equivalent in operating parameters, physical characteristics and
intended uses. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Additional Information: | None |
000097
1
Image /page/1/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 an abstract symbol that resembles a stylized caduceus or a series of human profiles. The symbol is composed of three curved lines that suggest the shape of a bird or a wing, with the lower part of the lines forming what could be interpreted as human faces.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Haney Manager, Dental Products Continuum Electro-Optics, Inc. 3150 Central Expressway Santa Clara, California 95051
JUL 11 2002
Re: K021616 Trade/Device Name: DeLight Dental Laser System and Endo 200 Tip Delivery System Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: May 14, 2002 Received: May 16, 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, 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 (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. Tom 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" (21CFR 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.
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
3
KO21616
Indications for Use Statement
510(k) Number (if known): pending
Device Name:
DELight Dental Laser System
Indications for Use:
- Tooth preparation to obtain access to the root canal 1.
-
- Pulpotomy
-
- Pulp extirpation
-
- Pulpotomy as an adjunct to root canal therapy
-
- Root canal debridement and cleaning
-
- Root canal preparation including enlargement
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stat Church
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021616
Prescription Use
(Per 21 CFR 801.109)
OR Over-the-Counter Use
(Optional Format 1-2-96)
000098