DELIGHT DENTAL ER: YAG LASER SYSTEM

K021616 · Continuum Electro-Optics, Inc. · GEX · Jul 11, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021616
• Device Name: DELIGHT DENTAL ER: YAG LASER SYSTEM
• Applicant: Continuum Electro-Optics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

DELight dental laser system; medical laser for endodontic procedures. Used by dentists in clinical settings. Performs tooth preparation, pulpotomy, pulp extirpation, and root canal cleaning/enlargement. Operates via laser energy delivery to dental tissue. Output assists clinician in performing root canal therapy; facilitates access and debridement. Benefits patient through precise tissue removal during endodontic treatment.

Clinical Evidence

No clinical data.

Technological Characteristics

Medical laser system for surgical use. Specific materials, energy source, and software details not provided in the source document.

Indications for Use

Indicated for patients requiring endodontic procedures including tooth preparation for root canal access, pulpotomy, pulp extirpation, root canal debridement, cleaning, and enlargement.

Regulatory Classification

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.

Predicate Devices

• WaterLase, Millennium dental laser system

Submission Summary (Full Text)

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21616

## 510(k) Summary

JUL 1 1 2002

| Submitter: | Continuum Electro-Optics, Inc.<br>3150 Central expressway<br>Santa Clara, CA 95051 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tom Haney<br>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<br>79-GEX |
| Equivalent Device(s): | WaterLase, Millennium dental laser system |
| Intended Use: | a) Tooth preparation to obtain access to the root canal<br>b) Pulpotomy<br>c) Pulp extirpation<br>d) Pulpotomy as an adjunct to root canal therapy<br>e) Root canal debridement and cleaning<br>f) Root canal preparation including enlargement |
| Comparison: | The BioLase WaterLase, Millennium dental laser system are<br>equivalent in operating parameters, physical characteristics and<br>intended uses. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Additional Information: | None |

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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.
- 2. Pulpotomy
- 3. Pulp extirpation
- 4. Pulpotomy as an adjunct to root canal therapy
- 5. Root canal debridement and cleaning
- 6. Root canal preparation including enlargement

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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)

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