(59 days)
No
The description focuses on light therapy parameters and a firmware timer, with no mention of AI or ML capabilities.
Yes
The device is described as a phototherapy lamp intended for the treatment of mild to moderate inflammatory acne vulgaris, directly indicating its therapeutic purpose.
No
Explanation: The device is intended for the treatment of inflammatory acne vulgaris using light therapy, not for diagnosing conditions. Its description and intended use clearly state it delivers light for treatment, not for detection, analysis, or monitoring of a disease state.
No
The device description explicitly states it is a "compact light source" with "light sources are narrow wavelength LEDs" and includes a "light unit" and "positioning arm," indicating it is a hardware device. While it mentions "firmware timer" and potential "off-the-shelf electronic devices related to treatment data acquisition and storage," these are components of a hardware system, not a standalone software device.
Based on the provided information, the Dermillume Pro1000 phototherapy lamp is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of acne vulgaris by applying light to the body. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a light source that delivers light to the body. It does not analyze samples (like blood, urine, or tissue) outside of the body, which is a key characteristic of IVDs.
- Lack of IVD Characteristics: There is no mention of the device being used to diagnose, monitor, or screen for a disease by examining samples in vitro.
Therefore, the Dermillume Pro1000 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dermillume Pro1000 phototherapy lamp is intended for dermatological use by trained licensed practitioners, specifically for the treatment of mild to moderate inflammatory acne vulgaris.
Product codes
GEX
Device Description
The Dermillume Pro1000 device is a compact light source that delivers high intensity narrow band blue and red light to the body for the treatment of acne vulgaris. The light sources are narrow wavelength LEDs that supply a spectral output of 414 ± 5 nm (blue) and 633 ± 5 nm (red). The device supplies 20 and 10 mW/cm² for blue and red light, respectively, at 4.6 inches distance from the skin surface.
The principal parts of the device are a light unit, positioning arm and firmware timer to control duration of exposure. Additional off-the-shelf electronic devices related to treatment data acquisition and storage may be supplied as user options.
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
dermatological use by trained licensed practitioners
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)
The performance data obtained from bench testing of the Dermillume device substantiates that the irradiance at a practicable distance from the skin surface (4.6") is comparable with the cited predicated devices. Additionally, the submission data demonstrates that the irradiance at the target surface is in conformance with recommendations of current clinical studies. The mode of operation, treatment area, and general principles for the treatment of inflammatory acne vulgaris with this device are the same as the predicate devices, ClearLight, Phototherapy System, Model Cl 420 (K013623), BLU-U, Model 4710 (K031805), Omnilux Blue (K030883) for the reduction and elimination of the acne-producing bacterium P. acnes. The Dermillume device combines the inflammatory acne-reducing properties of blue light with the red light improvement supported by a recent clinical acne treatment study. The output wavelength and irradiance are comparable to the predicate device, Omnilux Red (K030426). There are no significant adverse reactions observed in clinical studies using this technology. The device is safe and efficacious.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ClearLight, Phototherapy System, Model Cl 420 (K013623), BLU-U, Model 4710 (K031805), Omnilux Blue (K030883), & Omnilux Red (K030426)
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
Care Electronics, Inc. 12/23/04
Dermillume Phototherapy Device 501(k)
.
:
K043575 1 of 2
『EB』《《 4》2005』
| Applicant & Submitter: | Care Electronics, Inc. |
|---|---|
| Address: | 4700 Sterling Dr., Suite D |
| Boulder, CO 80301 | |
| Phone: | 303-444-2273 |
| Fax: | 303-447-3502 |
| Contact Person: | Thomas Moody |
| Preparation Date: | 12/23/04 |
| Device Submitted: | Dermillume Phototherapeutic Lamp |
| Proprietary Name: | Dermillume |
| Common Name: | Blue/Red Light Acne Treatment Lamp |
| Classification: | Class II Laser surgical instrument for use in General and Plastic |
| Surgery and in Dermatology. Product code: GEX | |
| Predicate Devices: | ClearLight, Phototherapy System, Model Cl 420 (K013623), BLU- |
| U, Model 4710 (K031805), Omnilux Blue (K030883), & Omnilux | |
| Red (K030426) | |
| Device Description: | The Dermillume Pro1000 device is a compact light source that |
| delivers high intensity narrow band blue and red light to the body | |
| for the treatment of acne vulgaris. The light sources are narrow | |
| wavelength LEDs that supply a spectral output of 414 ± 5 nm | |
| (blue) and 633 ± 5 nm (red). The device supplies 20 and 10 | |
| mW/cm² for blue and red light, respectively, at 4.6 inches | |
| distance from the skin surface. | |
| The principal parts of the device are a light unit, positioning arm | |
| and firmware timer to control duration of exposure. Additional off- | |
| the-shelf electronic devices related to treatment data acquisition | |
| and storage may be supplied as user options. | |
| Intended Use: | The Dermillume Pro1000 phototherapy lamp is intended for |
| dermatological use by trained licensed practitioners, specifically | |
| for the treatment of mild to moderate inflammatory acne vulgaris. |
1
re Electronics, Inc.
Dermillume Phototherapy Device 501(k)
revised 2/10/2005
510(k) Summary, contd.
The performance data obtained from bench testing of the Performance Data: Dermillume device substantiates that the irradiance at a practicable distance from the skin surface (4.6") is comparable with the cited predicated devices. Additionally, the submission data demonstrates that the irradiance at the target surface is in conformance with recommendations of current clinical studies. The mode of operation, treatment area, and general principles for the treatment of inflammatory acne vulgaris with this device are the same as the predicate devices, ClearLight, Phototherapy System, Model Cl 420 (K013623), BLU-U, Model 4710 (K031805), Omnilux Blue (K030883) for the reduction and elimination of the acne-producing bacterium P. acnes. The Dermillume device combines the inflammatory acne-reducing properties of blue light with the red light improvement supported by a recent clinical acne treatment study. The output wavelength and irradiance are comparable to the predicate device, Omnilux Red (K030426). There are no significant adverse reactions observed in clinical studies using this technology. The device is safe and efficacious. The Dermillume Pro1000 phototherapeutic lamp is substantially Substantial Equivalence: equivalent to the cited predicate devices for spectral output, mode of operation, operating principals as well as general and specific indications for use. All devices emit visible light for the treatment of dermatological conditions. Although there are some differences in the source of the emitted light and output intensity, these differences are minor and do not raise new questions of safety or efficacy. The Dermillume Pro1000 phototherapeutic lamp is substantially equivalent.
2
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2005
Mr. Thomas O. Moody President Care Electronics, Inc. 4700 Sterling Drive. Suite D Boulder, Colorado 80301
Re: K043575
Trade/Device Name: Dermillume Pro1000 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: January 20, 2005 Received: January 25, 2005
Dear Mr. Moody:
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. Thomas O. Moody
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/industry/support/index.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
510(k) Number (if known):
Device Name: Dermillume Pro1000
Indications For Use: The Dermillume Pro1000 phototherapy lamp is intended for dermatological use by trained licensed practitioners, specifically for the treatment of mild to moderate inflammatory acne vulgaris.
Prescription Use Yes (Part 21 CFR 801 Subpart D)
AND/OR
no Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K013575