(56 days)
Not Found
No
The description focuses on light therapy and does not mention any AI/ML components or functionalities.
Yes
The device is used to treat dermatological conditions, specifically acne, which falls under the definition of a therapeutic device.
No
The device is indicated to "treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris," which makes it a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "handheld, electrically-powered light therapy device," indicating it is a hardware device that produces light.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris." This describes a therapeutic treatment applied directly to the patient's skin.
- Device Description: The device is a "handheld, electrically-powered light therapy device that produces light at a wavelength of nominally 410 nm." This is a physical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of that.
The SpectraGenics ATS-1 is a therapeutic device used for light therapy treatment of acne.
N/A
Intended Use / Indications for Use
The SpectraGenics ATS-1 is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Product codes
GEX
Device Description
The SpectraGenics ATS-1 is a handheld, electrically-powered light therapy device that produces light at a wavelength of nominally 410 nm.
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
Clinical data is provided to demonstrate the safety and efficacy of the SpectraGenics ATS-1.
Key Metrics
Not Found
Predicate Device(s)
K013623, K030338, K030883, K040081, K041086, K051268, K032205
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.
0
K 060567
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness for the SpectraGenics ATS-1 is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and follows the HHS Publication FDA 95-4158 concerning the content and organization of a 510(k) summary.
| Applicant: | SpectraGenics, Inc. |
|---|---|
| Address: | 5880 West Las Positas Blvd., Suite 52 |
| Pleasanton, CA 94588-8522 | |
| Contact person: | Robert E. Grove, Ph.D. |
| Telephone: | (925) 398-2049 |
| Preparation date: | March 1, 2006 |
| Device Trade Name: | SpectraGenics ATS-1 |
| Common Name: | Light Therapy Device |
| Classification Name: | Laser Instrument, Surgical, Powered |
| (Laser surgical instrument for use in | |
| general and plastic surgery and | |
| dermatology) | |
| Regulation No. 878.4810 | |
| Product Code: GEX; Panel: 79 | |
| Legally Marketed Predicate Devices: | ClearLight Phototherapy System, |
| Model CL420 | |
| CureLight Ltd. | |
| K013623 |
iClear Phototherapy System,
Model FCGM0002
K030338
Omnilux Blue
Photo Therapeutics, Ltd.
K030883
Palomar LuxV Handpiece
Palomar Medical Technologies, Inc.
K040081 |
1
Palomar StarLux Pulsed Light System Palomar Medical Technologies, Inc. K041086
Radiancy Acne System with ClearTouch Light Unit Assembly K051268, K032205
The SpectraGenics ATS-1 is a handheld, electrically-powered light therapy device that produces light at a wavelength of nominally 410 nm.
The SpectraGenics ATS-1 is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The specifications and indications for use of the SpectraGenics ATS-1 arc substantially equivalent to those claimed in one or more of the clearances for the above-listed predicate devices.
Clinical data is provided to demonstrate the safety and efficacy of the SpectraGenics ATS-1.
The SpectraGenics ATS-1 is substantially cquivalent to the legally-marketed claimed predicate devices for the purposes of this 510(k) submission.
System Description:
Intended Use of the Device:
Performance Data:
Conclusion:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SpectraGenics, Inc. c/o Robert E. Groves, Ph.D. President & CEO 5880 West Las Positas Boulevard - Suite 52 Pleasanton, California 94588-8522
APR 2 8 2006
Re: K060567
Trade/Device Name: SpectraGenics ATS-1 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: March 1, 2006 Received: March 10, 2006
Dear Dr. Groves:
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. Iisting 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
3
Page 2 - Robert E. Groves, Ph.D.
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. 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 (240) 276-0115. 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.
Q. Malli
Mark N. Melke Director Division of General, Restorative
· and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
SpectraGenics ATS-1
66056
Indications For Use:
The SpectraGenics ATS-1 is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
eMee
(Division Sign Division of General, Restorative. and Neurological Devices
510(k) Number_ko60567
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