(27 days)
The Smart 2940 D laser is indicated for intraoral soft tissue surgery including dental soft tissue.
Smart 2940 D is an Er:YAG laser, having a flashlamp pumped, Erbium rod as the lasing medium. It is a laser with a wavelength of 2,940 nm. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.
The provided text is a 510(k) summary for the Cynosure Smart 2940 D laser. It directly states that no nonclinical or clinical performance data was provided. Therefore, it is not possible to describe acceptance criteria or a study proving the device meets them from the given document.
The submission relies on substantial equivalence to a predicate device (PhotoDent laser) for its market clearance, rather than presenting new performance data.
Here's a breakdown of why I cannot fulfill your request based on the provided input:
- A table of acceptance criteria and the reported device performance: Not available. The document states "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no test set data was provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no test set data was provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set data was provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser for surgery, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser for surgery, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no ground truth was established for performance data in this submission.
- The sample size for the training set: Not applicable, as no training set data was used for performance evaluation in this submission.
- How the ground truth for the training set was established: Not applicable, as no training set data was used for performance evaluation in this submission.
In summary, the provided document explicitly states that no performance data (nonclinical or clinical) was submitted. The clearance was based on substantial equivalence to a predicate device, meaning the new device shares fundamental technological characteristics and intended uses with an already legally marketed device.
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510(K) Summary <0313/7
MAY 2222003
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | April 24, 2003 |
| Device Trade Name: | Smart 2940 D laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | PhotoDent laser |
| Device Description: | Smart 2940 D is an Er:YAG laser, having a flashlamp pumped,Erbium rod as the lasing medium. It is a laser with a wavelength of2,940 nm. |
| Laser activation is by foot switch. Overall weight of the laser is 25Kg, and the size is 180x62x42 cm (HxWxD).Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase. | |
| Intended Use: | The Smart 2940 D laser is indicated for intraoral soft tissue surgery. |
| Comparison: | The Smart 2940 D laser is substantially equivalent to the PhotoDentlaser, with the same principle of operation, the same wavelength andessentially the same power range as the predicate devices for the sameindications for uses. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Smart 2940 D laser is another safe and effective device for softtissue surgery applications. |
| Additional Information: | none |
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, depicted with three parallel lines forming the wings and a flowing design for the body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 2003
Mr. George Cho Senior Vice President of Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K031317 Trade/Device Name: Smart 2940 D 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: April 24, 2003 Received: April 25, 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 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. 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. 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) you may obtain. 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 vours.
Mark n Milkin
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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510(k) Number (if known): < 0 3/3/ 7
Device Name: Smart 2940 D Laser
Indications For Use:
The Smart 2940 D laser is indicated for intraoral soft tissue surgery including dental soft tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mckinnon
Division Sign Off
vision Sign-Off) Division of General, Restorative and Neurological Devices
10(k) Number K031317
Over-The-Counter Use_
§ 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.