(40 days)
Not Found
No
The document describes a laser device for tattoo and lesion removal and hair lightening. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the hardware components and intended uses of the laser.
Yes
The device is indicated for treatment of various medical conditions, including tattoo removal, removal of pigmented lesions, hair removal, and treatment of vascular lesions. This falls under the definition of a therapeutic device designed to treat or alleviate an ailment or condition.
No
The device description and indications for use clearly describe a laser intended for treatment purposes (tattoo removal, lesion treatment, hair removal), not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a console, power supply, electronic circuit board, cooling system, LCD screen, handpiece with a light source, and a footswitch.
Based on the provided information, the SkinClear Q-Switched Nd: YAG Laser is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The SkinClear Q-Switched Nd: YAG Laser is a laser device that uses light energy to treat various skin conditions and remove tattoos and hair. It operates directly on the patient's skin.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples or the use of reagents typically associated with IVD tests.
Therefore, the SkinClear Q-Switched Nd: YAG Laser is a therapeutic laser device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SkinClear Q-Switched Nd:YAG Laser is indicated at the 1064 nm wavelength for dark ink tattoo removal of pigmented lesions, and the removal or lightening of hair. Indicated for use on all skin types (Fitzpatrick I-IV).
The SkinClear Q-Switched Nd:YAG Laser is indicated at the 532 nm wavelength for red ink tattoo removal, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, ephildes). Indicated for use on all skin types (Fitzpatrick I-IV).
Product codes
GEX
Device Description
The SkinClear Q-Switched Nd: YAG Laser is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD), a handpiece which contains the light source which is connected to the console by a power cord, and an on/off footswitch.
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)
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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1 c + 2
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DEC 1 6 2008
510(k) Summary
Global USA Distribution, LLC SkinClear O-Switched Nd: YAG Laser
| Submitter: | Global USA Distribution, LLC |
|---|---|
| Address: | 10723 Aquila Av. S. |
| Minneapolis, MN 55438 | |
| Contact Person: | Matt Makousky |
| Telephone: | 952-703-5373 |
| Facsimile: | 952-888-8887 |
| Date Prepared: | July 1, 2008 |
| Device Trade Name: | SkinClear Q-Switched Nd:YAG Laser |
| Classification Name: | Instrument, Powered, Laser |
| Legally Marketed Predicate Devices: Sandstone Medical Technologies, LLC |
UltraLight II Nd: YAG Laser System (K041011)
Description of the SkinClear Q-Switched Nd: YAG Laser:
The SkinClear Q-Switched Nd: YAG Laser is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD), a handpiece which contains the light source which is connected to the console by a power cord, and an on/off footswitch.
Intended Use of the : SkinClear Q-Switched Nd:YAG Laser:
The SkinClear Q-Switched Nd:YAG Laser is indicated at the 1064 nm wavelength for dark ink tattoo removal of pigmented lesions, and the removal or lightening of hair. Indicated for use on all skin types (Fitzpatrick I-IV).
The SkinClear Q-Switched Nd: YAG Laser is indicated at the 532 nm wavelength for red ink tattoo removal, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, ephildes). Indicated for use on all skin types (Fitzpatrick I-IV).
1
P.
Summary of technological characteristics:
The SkinClear Q-Switched Nd: Y AG Laser and the Sandstone Medical Technologies, LLC UltraLight II Nd: YAG Laser System share the same wavelengths, energy output, pulse duration, and pulse repetition rate.
Nonclinical Performance Data:
None
Clinical Performance Data:
None
Additional Information:
None requested at this time
Conclusion:
The SkinClear Q-Switched Nd:YAG Laser is substantially equivalent to other existing legally marketed laser systems currently in commercial distribution.
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Global USA Distribution, LLC % Underwriters Laboratory, Inc. Mr. Ned Devine 333 Pfingsten Road Northbrook, Illinois 60062
Re: K083272
Trade/Device Name: SkinClear™ Q-Switched Nd:YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
DEC 1 6 2008
Regulatory Class: II Product Code: GEX Dated: December 3, 2008 Received: December 4, 2008
Dear Mr. Devine:
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
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Page 2 - Mr. Ned Devine
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K08327
. i-f
Indications for Use
510(k) Number (if known):
Device Name: SkinClear™ Q-Switched Nd: Y AG Laser System
Indications for Use:
The SkinClear Q-Switched Nd: YAG Laser is indicated at the 1064 nm wavelength for dark ink tattoo removal, the removal of pigmented lesions. and the removal or lightening of hair. Indicated for use on all skin types (Fitzpatrick I-IV)
The SkinClear Q-Switched Nd: Y AG Laser is indicated at the 532 nm wavelength for red ink tattoo removal, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, ephildes). Indicated for use on all skin types (Fitzpatrick I-IV)
Prescription Use: X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mest R.P. Dyke for rx
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K083272