(75 days)
No
The summary describes a computer-controlled phototherapy system with selectable light doses, but there is no mention of AI, ML, image processing, or any data-driven decision-making or learning capabilities.
Yes
The device is described as a "phototherapy system" intended to "treat dermatological conditions" and "provide phototherapeutic light to the body." This aligns with the definition of a therapeutic device, which applies energy or materials to effect changes in the body or to treat conditions.
No
The device description and intended use indicate that the MultiClearXL is a phototherapy system used for treatment, not diagnosis, of dermatological conditions. It emits light for therapeutic purposes and does not describe any diagnostic function like image analysis or detection of diseases.
No
The device description explicitly lists hardware components such as a console trolley, control console, illumination assembly, extension arm, and protective eyewear, indicating it is a physical device with software control, not a software-only device.
Based on the provided information, the MultiClearXL Multiwavelength Targeted Phototherapy System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is intended to provide phototherapeutic light to the body to treat dermatological conditions. This involves applying light directly to the patient's skin.
- Device Description: The description details a system that emits light for treatment, including a console, illumination assembly, and handpiece. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to obtain diagnostic information. IVDs are designed for in vitro analysis.
Therefore, the MultiClearXL is a therapeutic device used for phototherapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MultiClearXL Multiwavelength Targeted Phototherapy System ("MultiClearXL") is intended to provide phototherapeutic light to the body. The MultiClearXL is generally indicated to treat dermatological conditions. The MultiClearXL's specific indication is for use in UVB phototherapy and PUVA photochemistry to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma and for the use of visible blue/violet light to treat moderate inflammatory acne vulgaris.
Product codes
GEX
Device Description
The MultiClearXL is a computer controlled, high-intensity lamp intended for treatment of dermatological disorders by emitting a homogenous UV light dose in the UVB, UVA, and visible blue/violet light ranges. The desired dose of UVA or UVB or blue/violet light is selected using controls on the system front panel. The system consists of a console trolley, control console, illumination assembly, an extension arm (light guide and hand piece) and protective eyewear for the operator and patient.
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)
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
K041994 1/3
510(k) SUMMARY
CURELIGHT LTD.'S MULTICLEARXL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
CureLight Ltd. 2 Ha'ilan Street Northern Industrial Zone, POB 247 Or Akiva 30600, Israel 011-972-4610-0969 Phone: Facsimile: 011-972-4626-0733
Contact Person: Yoram Harth, M.D.
Date Prepared: July 15, 2004
Name of Device and Name/Address of Sponsor
MultiClearXL Multiwavelength Targeted Phototherapy System CureLight Ltd. 2 Ha'ilan Street Northern Industrial Zone, POB 247 Or Akiva 30600, Israel
Common or Usual Name
Phototherapy System
Classification Name
Ultraviolet Lamp for Dermatologic Disorders
Predicate Devices
| Device Name: | Manufacturer: |
|---|---|
| MultiClear Multiwavelength Targeted | |
| Phototherapy System | CureLight |
| ClearLight | CureLight |
| ClearTouch Acne Therapy System | Radiancy |
1
041994 4/3
Intended Use / Indications for Use
The MultiClearXL Multiwavelength Targeted Phototherapy System ("MultiClearXL") is intended to provide phototherapeutic light to the body. The MultiClearXL is generally indicated to treat dermatological conditions. The MultiClearXL's specific indication is for use in UVB phototherapy and PUVA photochemistry to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma and for the use of visible blue/violet light to treat moderate inflammatory acne vulgaris.
Technological Characteristics
The MultiClearXL is a computer controlled, high-intensity lamp intended for treatment of dermatological disorders by emitting a homogenous UV light dose in the UVB, UVA, and visible blue/violet light ranges. The desired dose of UVA or UVB or blue/violet light is selected using controls on the system front panel. The system consists of a console trolley, control console, illumination assembly, an extension arm (light guide and hand piece) and protective eyewear for the operator and patient.
Substantial Equivalence
The MultiClearXL has the same intended use and indications and similar principles of operation and technological characteristics as a combination of the predicate devices. The MultiClearXL's specific indications
2
041994 3/3
are specific indications for at least one of the predicate devices. Any minor differences between the MultiClearXL and its predicate devices raise no new issues of safety or effectiveness. Thus, the MultiClearXL is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is arranged in a circular fashion, following the curve of the circle.
OCT 6 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CureLight Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson 555 Thirteenth Street NW Washington, D.C. 20004
Re: K041994
Trade/Device Name: MultiClearXL Multiwavelength Targeted Phototherapy System 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: July 23, 2004 Received: July 23, 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 for too barrow io 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.
4
Page 2 - Mr. Jonathan S. Kahan
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your of substantial equivalence of your device to a legally premated predicated. " ce 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 other Ecturers, 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,
Muriam 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
5
Indications for Use Statement
2041994 510(k) Number (if known):___
Device Name: MultiClearXL Multiwavelength Targeted Phototherapy System Indications for Use:
The MultiClearXL Multiwavelength Targeted Phototherapy System ("MultiClearXL") is intended to provide phototherapeutic light to the body. The MultiClearXL is generally indicated to treat dermatological conditions. The MultiClearXL's specific indication is for use in UVB phototherapy and PUVA photochemistry to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma and for the use of visible blue/violet light to treat moderate inflammatory acne vulgaris.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mirians C. Phovost (Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041994
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