(90 days)
ClearLight™ Phototherapy Device, Model CL-420
Not Found
No
The summary describes a light therapy device with a timer and stand, and there is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as a "Photodynamic Therapy Illuminator" intended to provide "phototherapeutic light" and is specifically indicated to "treat moderate inflammatory acne vulgaris". These terms clearly indicate a therapeutic purpose.
No
The device is described as providing "phototherapeutic light to the body" and is "generally indicated to treat dermatological indications," specifically "moderate inflammatory acne vulgaris." This indicates a therapeutic, rather than diagnostic, function.
No
The device description explicitly states it is a "compact light source" with "principal parts of the system include the light unit and floor stand with timer," indicating it is a hardware device.
Based on the provided information, the BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- BLU-U® Function: The BLU-U® is a light therapy device that applies light directly to the body (specifically the skin surface) for therapeutic purposes (treating acne). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it provides phototherapeutic light to the body to treat dermatological indications.
Therefore, the BLU-U® falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170 is intended to provide phototherapeutic light to the body. The BLU-U® is generally indicated to treat dermatological indications. The BLU-U® is specifically indicated to treat moderate inflammatory acne vulgaris.
Product codes
GEX
Device Description
The BLU-U® 4170 is a compact light source that delivers a uniform distribution of blue light to the body with a spectral output at a peak wavelength of 417 nm and a Full Width at Half Maximum (FWHM) of 30 nm (407 - 437 nm). The principal parts of the system include the light unit and floor stand with timer.
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)
No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). The BLU-U has the same spectral output, mode of operation, treatment area, and general operating principals as well as the same intended use, the same general and specific indications for use as the predicate device. A data base search has been performed to evaluate any adverse effects of the device that is currently marketed. for 807.92 No data submitted section 6[(b)(1)(2)(3c)]
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ClearLight™ Phototherapy Device, Model CL-420
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
031805 1/2
SEP - 9 2003
D U S λ®
WILMINGION MA 01887
TEL 978.657.7500
1 :: 978 657 9193 /www.Dusapharma.com
510(k) SUMMARY
DUSA Pharmaceuticals, Inc. Applicant & Submitter: 25 Upton Drive Address: Wilmington, MA 01887 978-657-7500 Phone: 978-657-9193 FAX: Contact Person: Scott Lundahl Preparation Date: June 9, 2003 BLU-U® Blue Light Photodynamic Therapy Device Submitted: Illuminator Model 4170 BLU-U® Proprietary Name: Blue Light Therapy Device Common Name: Laser surgical instrument for use in General and Classification Name: Plastic Surgery and in Dermatology. Product Code GEX ClearLight™ Phototherapy Device, Model CL-420 Predicate Device: The BLU-U® 4170 is a compact light source that Device Description: delivers a uniform distribution of blue light to the body with a spectral output at a peak wavelength of 417 nm and a Full Width at Half Maximum (FWHM) of 30 nm (407 - 437 nm). The principal parts of the system include the light unit and floor stand with timer. The BLU-U® Blue Light Photodynamic Therapy Intended Use: Illuminator Model 4170 is intended to provide phototherapeutic light to the body. The BLU-U® 4170 is generally indicated to treat dermatological The BLU-U® 4170 is specifically indications. indicated to treat moderate inflammatory acne vulgaris.
1
No performance data is required for this Class II Performance Data: device nor requested by the Food and Drug Administration (Office of Device Evaluation). The BLU-U has the same spectral output, mode of operation, treatment area, and general operating principals as well as the same intended use, the same general and specific indications for use as the predicate device. A data base search has been performed to evaluate any adverse effects of the device that is currently marketed. for 807.92 No data submitted section 6[(b)(1)(2)(3c)] The Model 4170 BLU-U® Photodynamic Therapy Substantial Equivalence: Illuminator is substantially equivalent to the previously cleared ClearLight™ Phototherapy Device, Model CL 420. The BLU-U has the same intended use and has the same general and specific indications for use as the Clearlight™. The spectral output, mode of operation, treatment area, and general operating principals for the BLU-U® are similar to or the same as the Clearlight™. The BLU-U® and the ClearLight™ are both light devices that are used to treat dermatological conditions by exposing the surface of the skin to light at precise wavelengths. Although there are some differences in method by which each device produces light. these differences do not raise new question of safety or Thus, the BLU-U® is substantially efficacy. equivalent.
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 features a stylized eagle with its head facing left. The eagle is composed of three curved lines that suggest feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2003
Mr. Scott Lundahl Director of Regulatory Affairs (Acting) DUSA Pharmaceuticals, Inc. 25 Upton Drive Wilmington, Massachusetts 01887
Re: K031805 Trade/Device Name: BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170 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: June 9, 2003 Received: June 11, 2003
Dear Mr. Lundahl:
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 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. Scott Lundahl
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 STATEMENT
510(k) Number: K031805
(if known)
BLU-U® Blue Light Photodynamic Therapy Illuminator Device Name: Model 4170
The BLU-U® Blue Light Photodynamic Therapy Indications for Use: Illuminator Model 4170 is intended to provide phototherapeutic light to the body. The BLU-U® is generally indicated to treat dermatological indications. The BLU-U® is specifically indicated to treat moderate inflammatory acne vulgaris.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE OF ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K631805