(284 days)
Not Found
No
The description focuses on light therapy and image capture for patient data storage, with no mention of AI/ML for analysis or decision-making.
Yes
The device is intended to provide phototherapeutic light to the body and treat dermatological conditions, specifically moderate inflammatory acne vulgaris, which aligns with the definition of a therapeutic device.
No
The device description and intended use clearly state that the ClearLight Phototherapy System is a "high intensity lamp intended for the therapy of dermatological disorders" and "intended to provide phototherapeutic light to the body" to "treat moderate inflammatory acne vulgaris". Its purpose is therapeutic, not diagnostic. While it has a camera for capturing digital images, this is used for recording patient data, not for making a diagnosis.
No
The device description explicitly lists hardware components such as a high intensity lamp, optical system, mechanical fixture, electronic unit, and camera.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices 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 of the body ("in vitro").
- ClearLight System Function: The ClearLight Phototherapy System is a device that applies light directly to the body for therapeutic purposes (treating acne). It does not analyze samples taken from the body.
The description clearly states its intended use is to "provide phototherapeutic light to the body" and "treat dermatological conditions." This is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The ClearLight Phototherapy System is intended to provide phototherapeutic light to the body. The ClearLight is generally indicated to treat dermatological conditions. The ClearLight is specifically indicated to treat moderate inflammatory acne vulgaris.
Product codes
GEX
Device Description
The ClearLight Therapy System is a high intensity lamp intended for the therapy of dermatological disorders such as acne vulgaris by emitting visible light in the violet-blue range with 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 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, an electronic unit to control the duration, and power of the emitted radiation and to capture and store patient data via a touch screen (i.e., control console), and a camera for capturing digital images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body, skin
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
The preclinical testing includes Electrical Safety and EMC testing, including the requirements of IEC 60601-1 "Medical Electrical Equipment Part 1 - General Requirements for Safety" and was tested in accordance to Medical Directive 93/42/EEC - EN 55011: 1998 + A1(99). Class A and IEC 60601-1-2 "Collateral Standard: Medical Electrical Equipment Electromagnetic Compatibility - Requirements and Tests." ANSI/ESNA RP-27 1-96 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements ANSI/ESNA RP-27.3-96 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification Labeling.
In vitro testing demonstrated that exposure to high intensity narrow band light induced eradication of p. acnes by endogenic porphyrins.
Clinical data from the trial of the ClearLight device for the treatment of dermatological conditions supports substantial equivalence and demonstrates that the ClearLight device is safe and effective for the treatment of acne vulgaris.
Key Metrics
Not Found
Predicate Device(s)
Avex Industries, Inc.'s Phototherapeutix, National Biological Corporation's Derma-Wand, PhotoMedex, Inc.'s XTrac Excimer Laser System, Model AL 7000, Respironics, Inc.'s Wallaby 3 Phototherapy System
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
8/16/02
510(k) SUMMARY
CureLight's ClearLight Phototherapy Device (K013623)
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.
| Phone: | +972 (52) 691764 |
|---|---|
| Facsimile: | +972 (4) 8374897 |
Dr. Yoram Harth Contact Person:
August 7, 2002 Date Prepared:
Name of Device and Name/Address of Sponsor
ClearLight Phototherapy Device, Model CL 420
CureLight Ltd. 2 Ha'ilan Street Northern Industrial Zone, POB 247 Or Akiva 30600, Israel
Common or Usual Name
Light Therapy Device
Classification Name
Ultraviolet Dermatological Light
Predicate Devices
Avex Industries, Inc.'s Phototherapeutix National Biological Corporation's Derma-Wand PhotoMedex, Inc.'s XTrac Excimer Laser System, Model AL 7000 Respironics, Inc.'s Wallaby 3 Phototherapy System
1
Kc13623 2/3
Intended Use / Indications for Use
The ClearLight Phototherapy System is intended to provide phototherapeutic light to the body. The ClearLight is generally indicated to treat dermatological conditions. The ClearLight is specifically indicated to treat moderate inflammatory acne vulgaris.
Technological Characteristics
The ClearLight Therapy System is a high intensity lamp intended for the therapy of dermatological disorders such as acne vulgaris by emitting visible light in the violet-blue range with 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 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, an electronic unit to control the duration, and power of the emitted radiation and to capture and store patient data via a touch screen (i.e., control console), and a camera for capturing digital images.
Performance Data
The preclinical testing includes Electrical Safety and EMC testing, including the requirements of IEC 60601-1 "Medical Electrical Equipment Part 1 - General Requirements for Safety" and was tested in accordance to Medical Directive 93/42/EEC - EN 55011: 1998 + A1(99). Class A and IEC 60601-1-2 "Collateral Standard: Medical El'ectrical Equipment Electromagnetic Compatibility - Requirements and Tests." ANSI/ESNA RP-27 1-96 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements ANSI/ESNA RP-27.3-96 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification Labeling.
In vitro testing demonstrated that exposure to high intensity narrow band light induced eradication of p. acnes by endogenic porphyrins.
Clinical data from the trial of the ClearLight device for the treatment of dermatological conditions supports substantial equivalence and demonstrates that the ClearLight device is safe and effective for the treatment of acne vulgaris.
2
Koi 3623 3/3
Substantial Equivalence
CureLight's ClearLight is substantially equivalent to other legally marketed Ultraviolet Dermatological Light devices. The ClearLight has the same intended use and general indications for use, and similar principles of operation and technological characteristics as the previously cleared predicate Avex Industries Ltd.'s Phototherapeutix devices; National Biological Corporation's Derma-Wand; PhotoMedex, Inc.'s XTrac Excimer Laser System, Model AL 7000; and Respironics Inc.'s Wallaby 3 Phototherapy System. In addition, the ClearLight's specific indication for use in subsumed within the general indications for use and encompassed by the specific indications for use of its predicate devices.
The ClearLight and its predicate devices are all light device that are used to treat dermatological conditions by exposing the surface of the skin to light at precise wavelengths. Although there are differences in the technological characteristics of the ClearLight and its predicate devices, those differences do not raise new questions of safety or efficacy. Thus, the ClearLight is substantially equivalent.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, arranged in a stacked formation. The profiles are black and have a flowing, abstract design. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Curclight, LTD c/o Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109
Rc: K013623
Trade/Device Name: Clearlight Phototheraphy System, Model CL 420 Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: May 23, 2002 Received: May 23, 2002
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 cither 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 docs 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 setforth 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) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrlv/dsma/dsmamain.html
Sincerely yours,
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 Form
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ClearLight Phototherapy Device
Indications for Use:
The ClearLight Phototherapy System is intended to provide phototherapeutic light to the body. The ClearLight is generally indicated to treat dermatological conditions. The ClearLight is specifically indicated to treat moderate inflammatory acne vulgaris.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aller Tall (Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number C013623
Prescription Use _ A (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use_ (Optional Format 1-2-96)