(20 days)
Not Found
No
The device description focuses on the physical components and light parameters, with no mention of AI, ML, or related concepts like image processing or data analysis for treatment decisions.
Yes
The device is explicitly stated to be a "Phototherapy System" and its intended use is to "provide phototherapeutic light" to treat various medical conditions such as acne and muscle/joint pain.
No
The device description and intended use indicate that the Clear100™ Phototherapy System provides therapeutic light for treatment purposes (e.g., acne, muscle/joint pain) and does not mention any diagnostic functions or capabilities.
No
The device description explicitly details hardware components such as a high intensity lamp, optical system, mechanical fixture, and timer unit, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the Clear100™ Phototherapy System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing phototherapeutic light to the body to treat acne and provide temporary relief for muscle and joint issues. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a light-emitting system designed to deliver light energy to the body. It does not mention any components or processes related to analyzing biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD Keywords: There are no mentions of terms typically associated with IVDs such as "in vitro," "sample," "assay," "reagent," "analyte," or "diagnosis."
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Clear100™ directly interacts with the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Clear100™ Phototherapy System (" Clear100™ ") is intended to provide phototherapeutic light to the body. The Clear100 ™ is indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
Product codes
GEX, ILY
Device Description
The Clear100™ Therapy System is a high intensity lamp emitting visible light in the violet-blue range (405 nm to 420 nm) and in the near infrared range (850-890nm) with a fluency of light ranging between 50-200 mW/cm2. The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and near infrared range with an optical system for controlling spectra and beam parameters of the light source. It also includes a mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area, and a timer unit to indicate the duration of light treatment.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CureLight Ltd.'s ReClear™
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.
0
JUN 3 0 2004
1/2
510(k) SUMMARY
CureLight's Clear100
CureLight Ltd. 2 Ha'ilan Street Northern Industrial Zone, POB 247 Or Akiva 30600, Israel.
| Phone: | +972 4 6100969 |
|---|---|
| Facsimile: | +972 4 6260733 |
Contact Person: Dr. Yoram Harth
Date Prepared: May 18th, 2004
Name of Device and Name/Address of Sponsor
Clear100™ Phototherapy Device, Model FGCM0002
CureLight Ltd. 2 Ha'ilan Street Northern Industrial Zone, POB 247 Or Akiva 30600, Israel
Common or Usual Name
Light Therapy Device
Classification Name
Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology
Predicate Devices
CureLight Ltd.'s ReClear™
1
2/2 Ko41569
Intended Use
The Clear100™ Phototherapy System (" Clear100™ ") is intended to provide phototherapeutic light to the body. The Clear100 ™ is indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
Technological Characteristics
The Clear100™ Therapy System is a high intensity lamp emitting visible light in the violet-blue range (405 nm to 420 nm) and in the near infrared range (850-890nm) with a fluency of light ranging between 50-200 mW/cm2. The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and near infrared range with an optical system for controlling spectra and beam parameters of the light source. It also includes a mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area, and a timer unit to indicate the duration of light treatment.
Substantial Equivalence
The Clear100™ has the same intended use and indications for use and very similar technological characteristics as the CureLight ReClear. The minor technological differences between these devices, i.e., the number of lamps they contain and the type of timer, do not raise any new questions of safety or effectiveness. Thus, Clear100™ is substantially equivalent to its predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its body and wings. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2004
CureLight Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109
Re: K041569
Trade/Device Name: Clear 100™ Phototherapy System Regulation Number: 21 CFR 878.4810, 21 CFR 890.5500 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology; Infrared lamp Regulatory Class: II Product Code: GEX, ILY Dated: June 10, 2004 Received: June 10, 2004
Dear Mr. Kahan:
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.
3
Page 2 - Mr. Jonathan S. Kahan
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. 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,
Miriam C. Provost
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
4
Indications for Use Form
K041569 510(k) Number:
Device Name:
Clear100™ Phototherapy System
Indications for Use:
The Clear100™ Phototherapy System (" Clear100™ ") is intended to provide phototherapeutic light to the body. The Clear100 ™ is indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
Prescription Use _V (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 2003)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________