(27 days)
Not Found
Not Found
No
The summary describes a standard pulsed laser device with no mention of AI or ML components or functionalities.
Yes
The device is indicated for benign vascular lesions and hair removal, which are conditions that it is intended to mitigate or treat.
No
The device description and intended use indicate the SMARTEPIL Laser is used for therapeutic procedures like treating benign vascular lesions and hair removal, not for diagnosing medical conditions.
No
The device description clearly outlines physical hardware components including a laser, switches, power requirements, weight, and dimensions, indicating it is not software-only.
No, the SMARTEPIL Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- SMARTEPIL Laser Function: The SMARTEPIL Laser is a therapeutic device that uses laser energy to treat conditions on the body (benign vascular lesions and hair removal). It does not analyze biological specimens.
The description clearly indicates it's a laser used for direct treatment, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The SMARTEPIL Laser is indicated for benign vascular lesions and hair removal.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Data: None
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB 0 7 2002
501(K) SUMMARY
K020107 -
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior 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, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Acclaim Laser |
| Device Description: | 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. |
| Intended Use: | The SMARTEPIL Laser is indicated for benign vascular
lesions and hair removal. |
| Comparison: | The SMARTEPIL Laser is substantially equivalent to
the Cynosure Acclaim Laser. They are both pulse
Nd: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 effective
device for dermatological vascular lesions and hair
removal application. |
1
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.
2
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
3
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