(24 days)
BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170, 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 any data processing that would suggest the use of such technologies. The performance study section also indicates no data was required, further suggesting a simple device without complex algorithms.
Yes
The device is intended to provide phototherapeutic light to the body and is specifically indicated to treat moderate inflammatory acne vulgaris, which aligns with the definition of a therapeutic device.
No
The device is intended to provide phototherapeutic light to the body to treat dermatological indications, specifically moderate inflammatory acne vulgaris. It is a light source for therapy, not for diagnosis.
No
The device description explicitly states the principal parts include a "light unit head and floor stand with timer," indicating physical hardware components beyond just software.
Based on the provided information, the PanaLight-BLU™ Illuminator, Model 4175 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide phototherapeutic light to the body" to treat dermatological indications, specifically moderate inflammatory acne vulgaris. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "compact light source" that delivers light to the body. This aligns with a therapeutic device, not one used to examine samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, the PanaLight-BLU™ is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The PanaLight-BLU™ Illuminator, Model 4175 is intended to provide phototherapeutic light to the body. The PanaLight-BLU™ is generally indicated to treat dermatological indications. The PanaLight-BLU™ is specifically indicated to treat moderate inflammatory acne vulgaris.
Product codes
GEX
Device Description
The PanaLight-BLU™ is a compact light source that delivers a uniform distribution of narrowband blue light to the body with a spectral output at a peak wavelength of 417 ± 5 nm. The principal parts of the system include the light unit head and floor stand with timer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
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 has it been requested by the Food and Drug Administration (Office of Device Evaluation). The PanaLight-BLU™ has the same spectral output, mode of operation, treatment area, and general operating principals as well as the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170, 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.
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DEC 1 0 2004
510(k) Summary of Safety and Effectiveness for the DUSA PanaLight-BLU™ Illuminator, Model 4175
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This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SDMA 1990 and 21 CFR 807.92.
| Applicant & Submitter: | DUSA Pharmaceuticals, Inc. |
|---|---|
| Address: | 25 Upton Drive |
| Wilmington, MA 01887 | |
| Phone: | 978-657-7500 |
| FAX: | 978-657-9193 |
| Contact Person: | Scott Lundahl |
| Preparation Date: | November 15, 2004 |
| Device Submitted: | PanaLight-BLU™ Illuminator, Model 4175 |
| Proprietary Name: | PanaLight-BLU™ |
| Common Name: | Blue Light Illuminator |
| Classification Name: | Laser surgical instrument for use in General |
| and Plastic Surgery and in Dermatology. | |
| Product Code GEX | |
| Predicate Devices: | BLU-U® Blue Light Photodynamic Therapy |
| Illuminator Model 4170 and ClearLight™ | |
| Phototherapy Device, Model CL-420 | |
| Device Description: | The PanaLight-BLU™ is a compact light |
| source that delivers a uniform distribution of | |
| narrowband blue light to the body with a | |
| spectral output at a peak wavelength of | |
| $417 \pm 5$ nm. The principal parts of the system | |
| include the light unit head and floor stand with | |
| timer. | |
| Intended Use: | The PanaLight-BLU™ Illuminator, Model 4175 |
| is intended to provide phototherapeutic light to | |
| the body. The PanaLight-BLU™ is generally | |
| indicated to treat dermatological indications. | |
| The PanaLight-BLU™ is specifically indicated | |
| to treat moderate inflammatory acne vulgaris. | |
| Performance Data: | No performance data is required for this Class |
| II device nor has it been requested by the Food | |
| and Drug Administration (Office of Device | |
| Evaluation). The PanaLight-BLU™ has the | |
| same spectral output, mode of operation, | |
| treatment area, and general operating | |
| principals as well as the same intended use. |
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the same general and specific indications for use as the predicate devices. Based on an analysis of of the overall performance characteristics, no significant differences exist and therefore the PanaLight-BLU™ raises no new questions of safety or efficacy.
- Substantial Equivalence: PanaLight-BLU™ The Illuminator is substantially equivalent to the previously cleared BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170, and to the previously cleared ClearLight™ Phototherapy Device, Model CL-420.
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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
Mr. Scott Lundahl Vice President Regulatory Affairs DUSA Pharmaceuticals, Inc. 25 Upton Drive Wilmington, Massachusetts 01887
Re: K043164
Trade/Device Name: PanaLight-BIJUTM Illuminator 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: November 15, 2004
Received: November 16, 2004
Dear Mr. Lundahl:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10) use stated in the encreate) to regars and ment date of the Medical Device Amendments, or to conniner co May 20, 1976, the excordance with the provisions of the Federal Food, Drug, de vices that have boon require approval of a premarket approval application (PMA). and Costiere Hor (110. (110.) that the device, subject to the general controls provisions of the Act. The I ou may, merclore, manies are as act include requirements for annual registration, listing of general controls provisions of the rise, 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 If your device is olasbilled (600 a00 ro) als. Existing major regulations affecting your device can inay be subject to such additions, 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 i Toase oc advisod that I Dr o abount that your device complies with other requirements of the Act that I DT has made a assid regulations administered by other Federal agencies. You must or any I odetar state and the equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K F art 607); adoling (21 CFR Part 820); and if applicable, the electronic for in the quany byevisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 (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 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
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INDICATIONS FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ (if known)
Device Name: PanaLight-BLU™ Illuminator
Indications for Use: The PanaLight-BLU™ Model 4175 is intended to provide phototherapeutic light to the body. The PanaLight-BLU™ is generally indicated to treat dermatological indications. The PanaLight-BLU™ is specifically indicated to treat moderate inflammatory acne vulgaris.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE OF ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-G Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________