(27 days)
The SMARTEPIL Laser is indicated for benign vascular lesions and hair removal.
The SMARTEPIL Laser is a pulse Nd:YAG laser utilizing the Nd-YAG crystal as the lasing medium. It is a pulsed laser with a wavelength of 1064nm. Laser activation is either by a finger switch or a footswitch. Overall weight of the laser is 200lbs, and the size is 92cm x 40cm x 80cm (H x W x D). Electrical requirement is 220VAC, 13A, 50-60 Hz, single phase.
The provided 510(k) summary for the SMARTEPIL laser system does not contain information about acceptance criteria or a study proving the device meets them. The document explicitly states "Non-clinical Performance Data: None" and "Clinical Performance Data: None."
This is a pre-amendments 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical or performance data as would be required for more complex or novel devices today.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.
The closest relevant information is contained in the "Conclusion" section of the 510(k) summary:
- Conclusion: "The SMARTEPIL Laser is another safe and effective device for dermatological vascular lesions and hair removal application." This statement serves as the overall conclusion, but it's not supported by specific performance metrics or studies within this document.
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FEB 0 7 2002
501(K) SUMMARY
K020107 -
| Submitter: | Cynosure, Inc.10 Elizabeth DriveChelmsford, MA 01824 |
|---|---|
| Contact: | George ChoSenior Vice President of Medical Technology |
| Date Summary Prepared: | January 10, 2002 |
| Device Trade Name: | SMARTEPIL |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser79-GEX21 CFR 878.48 |
| Equivalent Device: | Acclaim Laser |
| Device Description: | The SMARTEPIL Laser is a pulse Nd:YAG laserutilizing the Nd-YAG crystal as the lasing medium. It isa pulsed laser with a wavelength of 1064nm.Laser activation is either by a finger switch or afootswitch. Overall weight of the laser is 200lbs, and thesize is 92cm x 40cm x 80cm (H x W x D).Electrical requirement is 220VAC, 13A, 50-60 Hz,single phase. |
| Intended Use: | The SMARTEPIL Laser is indicated for benign vascularlesions and hair removal. |
| Comparison: | The SMARTEPIL Laser is substantially equivalent tothe Cynosure Acclaim Laser. They are both pulseNd:YAG lasers for the identical indications for use. |
| Non-clinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The SMARTEPIL Laser is another safe and effectivedevice for dermatological vascular lesions and hairremoval application. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 7 2002
Mr. George Cho Senior Vice President, Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K020107 Trade/Device Name: SMARTEPIL 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: January 10, 2002 Received: January 11, 2002
Dear Mr. Cho:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is the the may are researced in interests for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regary manological Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Truc commerce prior to May 26, 1970, the enaomises with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosment Act (Act) that to not require approvide on the general controls provisions of the Act. The You may, therefore, market the device, basjon to the securements for annual registration, listing of general Controls provisions of the 120 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). in 1 II your device is classified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may oe subject to such additional controller and the may on your of the 898. In addition, FDA may be found in the Out of reacts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not nean Please be advised that I Dri 3 issualles of wouldevice complies with other requirements of the Act that IDA has made a decerminations administered by other Federal agencies. You must of any I cachartes and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fall 807), labeling (21 CFR Part 807), good and if applicable, the electronic (2001), and if applicable, the electronic form in the quality systems (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) I his letter wilf anow you to ought tinding of substantial equivalence of your device to a legally prematics notineation. "The 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 If you desire specific au roo re: 75 m witro diagnostic devices), please contact the Office of additionally 21 Of ICPart 0659. Additionally, for questions on the promotion and advertising of Compliance at (301) 597 1859 - 128215 12339, liance at (301) 594-4639. Also, please note the your do roo, pirals country by reference to premarket notification" (21CFR Part 807.97). regulation chitting, "Misoranang of esponsibilities under the Act may be obtained from the Ourclaimmation 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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510(k) Number (if known): ≤ 020107
Device Name: SMARTEPIL
Indication for Use:
The SMARTEPIL Laser is indicated for benign vascular lesions and hair removal.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per21 CFR 801.109)
OR
Over-the-Counter Use
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K020107
§ 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.