(197 days)
The ReClear™ Phototherapy System ("ReClear™") is intended to provide phototherapeutic light to the body. The ReClear™ is specifically indicated to emit visible blue/violet light for treatment of moderate inflammatory acne vulgaris. It also emits 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.
The ReClear emits in the range of visible blue/violet light (405-420nm) and infrared light (850 nm to 900 nm) with a fluency of light up to 200mW/cm². The system also includes an optical system for controlling spectra and beam parameters of the light source, a mechanical fixture for holding the light source at an adjustable distance and direction in relation to the skin treatment area, and a timer unit to control the duration of the emitted radiation.
The provided text is a 510(k) summary for the CureLight ReClear™ Phototherapy System. It details the device's intended use and technological characteristics but does not contain any information about acceptance criteria, device performance results, sample sizes, expert involvement, or any specific studies proving the device meets acceptance criteria.
The document relies on demonstrating substantial equivalence to previously cleared predicate devices (K030338, K001179, K020017, and K020851) rather than presenting new performance data from a specific study for the ReClear™ itself.
Therefore, I cannot populate the requested table or answer most of the questions based on the provided text.
Here is what can be inferred from the document regarding the device and its predicate:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The basis for clearance is "substantial equivalence" to predicate devices, implying that the ReClear™'s specifications and intended uses are similar enough to already approved devices.
- Reported Device Performance: Not reported for the ReClear™ explicitly. The document states its technological characteristics, which are the basis for substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no new specific performance study is detailed for the ReClear™ device in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no new specific performance study is detailed for the ReClear™ device in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no new specific performance study is detailed for the ReClear™ device in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a phototherapy system, not an AI diagnostic tool, and no MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a phototherapy system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable as no new specific performance study is detailed for the ReClear™ device in this document. The "ground truth" for substantial equivalence is the FDA's prior clearance of the predicate devices based on their safety and effectiveness data.
8. The sample size for the training set
- Not applicable as no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
- Not applicable as no training set for an algorithm is mentioned.
Summary of what the document DOES provide:
- Intended Use:
- Visible blue/violet light (405-420nm): Treatment of moderate inflammatory acne vulgaris.
- Infrared light (850-900nm): Temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
- Technological Characteristics:
- Emits visible blue/violet light (405-420nm) and infrared light (850-900nm).
- Fluency of light up to 200mW/cm².
- Includes an optical system, mechanical fixture, and timer unit.
- Substantial Equivalence Basis:
- Regulatory Clearance Date: April 15, 2004
- Applicant: CureLight Ltd.
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Ko33183 1/2
APR 1 5 2004
510(k) SUMMARY
CureLight's ReClear™
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: September 23rd, 2003
Name of Device and Name/Address of Sponsor
ReClear1M Phototherapy Device, Model FGCM0012
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
Light Force Therapy's SuperNova/Acubeam (K001179), MedX Health
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K0331/3 2/2
Corp. 's MedX 1000 series (K 020017), C&H international Inc.'s TDP lamp (K020851), and Curelight's iClear Phototherapy System (K030338).
Intended Use
The ReClear™ Phototherapy System ("ReClear™") is intended to provide phototherapeutic light to the body. The ReClear™ is specifically indicated to emit visible blue/violet light for treatment of moderate inflammatory acne vulgaris. It also emits 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 ReClear emits in the range of visible blue/violet light (405-420nm) and infrared light (850 nm to 900 nm) with a fluency of light up to 200mW/cm². The system also includes an optical system for controlling spectra and beam parameters of the light source, a mechanical fixture for holding the light source at an adjustable distance and direction in relation to the skin treatment area, and a timer unit to control the duration of the emitted radiation.
Substantial Equivalence
The CureLight ReClear™ is a modification to the iClear™ that has already been cleared by FDA to provide phototherapeutic light to the body. The ReClear™ blue/violet light mode has the same characteristics and technology as CureLight's iClear (K030338). In contrast to the iClear that is intended to treat inflammatory acne lesions, the ReClear™ emits also infrared light that is intended to 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. The ReClear™ infrared mode is substantially equivalent to Light Force Therapy, Acubeam (K001179), and MedX Health Corp. , MedX 1000 series , (K020017) and C&H International Inc.'s TDP lamp (C&H international Inc.) ( K020851) all of which FDA has already cleared for the same intended use and indications. Thus, ReClear™ is substantially equivalent to its predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or other bird-like figure with three wing-like extensions.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2004
CureLight Ltd C/o Jonathan S. Kahan Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109
Re: K033183
Trade/Device Name: ReClear 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 Dermatology, Infrared lamp Regulatory Class: II Product Code: GEX, ILY Dated: February 5, 2004
Dear Mr. Kahan:
Received: February 5, 2004
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 10 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.
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Page 2 -- Jonathan S. Kahan
This letter will allow you to begin marketing your device as described in your Section 510(k) I market notification. The FDA finding of substantial equivalence of your device to a legally prematics nevice 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 other general mornational 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
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Indications for Use Form
K033183 510(k) Number:
Device Name:
ReClear Phototherapy System
Indications for Use:
The ReClear™ Phototherapy System ("ReClear™") is intended to provide The ReClear™ Thototherapy BystenT\ 1.6 Clear™ is specifically indicated
phototherapeutic light to the body. The ReClear™ is specifically indicated photother apedic light to the sees.
to emit visible blue/violet light to treat moderate inflammatory acne to emit visible blue. Violet ingility to the temporary increase in local blood vingaris and 11s nght chergy tof minor muscle and joint aches, pains and ciffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
Prescription Use _ (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)
mirian C. Phorost (Division Sign-Off)
(Optional Format 2003)
Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.