(152 days)
Fotona Fidelis, American Dental Technologies Pulsemaster Er:Y:YAG
Not Found
No
The description focuses on the physical characteristics and basic operation of a laser system, with no mention of AI, ML, or related concepts.
Yes
The device is used for medical procedures such as ablation, incision, excision, vaporization, and coagulation of intraoral tissue, and specifically mentions caries removal and cavity preparation, all of which are considered therapeutic interventions.
No
The device is described as a laser system for ablation, incision, excision, vaporization, and coagulation, all of which are treatment-oriented actions rather than diagnostic ones. The mentions of caries removal, cavity preparation, and enamel etching further solidify its role in therapeutic procedures.
No
The device description clearly outlines a physical laser system with hardware components (Er:YAG crystal rod, footswitch, power requirements, weight, and dimensions), indicating it is 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 use clearly states that the device is used for "ablation, incision, excision, vaporization and coagulation of hard and soft intraoral tissue." These are direct surgical or therapeutic procedures performed on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.
- Device Description: The description details a laser system used for direct tissue interaction, not for analyzing biological samples.
Therefore, the Smart 2940D Er:YAG Laser system is a therapeutic or surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Smart 2940D is indicated for ablation, incision, excision, coagulation and vaporization of intraoral hard and soft tissue. The Smart 2940D Er:YAG Laser system is indicated to be used for ablation, incision, excision, vaporization and coagulation of hard and soft intraoral tissue. The procedures include caries removal, cavity preparation and enamal etching.
Product codes
GEX
Device Description
Smart 2940D is a Er:YAG laser, having a Er:YAG crystal rod as the lasing medium. It is a laser with a wavelength of 2,940 nm. Laser activation is by footswitch. Overall weight of the laser is 47 Kg, and the size is 145x23x65 cm (HxWxD). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral
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)
Fotona Fidelis, American Dental Technologies Pulsemaster Er:Y:YAG
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.
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OCT = 1 2003
:
K031389 1 of 1
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510(K) Summary
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | May 1, 2003 |
| Device Trade Name: | Smart 2940D Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Fotona Fidelis & American Dental Technologies Pulsemaster Er:Y:YAG |
| Device Description: | Smart 2940D is a Er:YAG laser, having a Er:YAG crystal rod as the
lasing medium. It is a laser with a wavelength of 2,940 nm. |
| | Laser activation is by footswitch. Overall weight of the laser is 47 Kg,
and the size is 145x23x65 cm (HxWxD). |
| | Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase. |
| Intended Use: | The Smart 2940D is indicated for ablation, incision, excision,
coagulation and vaporization of intraoral hard and soft tissue. |
| Comparison: | The Smart 2940D laser has an equivalent indication for uses, the same
principle of operation, the same wavelength and essentially the same
pulse energy range as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Smart 2940D laser is another safe and effective device for
intraoral hard and soft tissue applications. |
| 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 graphic of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
OCT - 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K031389 Trade/Device Name: Smart 2940D Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 15, 2003 Received: August 18, 2003
Dear Mr. Cho:
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 cither 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 (OS) 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. George Cho
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), please contact the Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
for 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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