DERMILLUME, MODEL PRO1000

K043575 · Care Electronics, Inc. · GEX · Feb 24, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043575
• Device Name: DERMILLUME, MODEL PRO1000
• Applicant: Care Electronics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Dermillume Pro1000 is a compact phototherapeutic lamp delivering high-intensity narrow-band blue (414 ± 5 nm) and red (633 ± 5 nm) light to the skin. Used by trained licensed practitioners in clinical settings to treat mild to moderate inflammatory acne vulgaris. Device consists of a light unit, positioning arm, and firmware-based timer to control exposure duration. Blue light targets P. acnes bacteria; red light provides therapeutic improvement. Practitioners position the device 4.6 inches from the skin surface to deliver 20 mW/cm² (blue) or 10 mW/cm² (red) irradiance. Optional off-the-shelf electronics may be used for treatment data acquisition and storage. Output helps reduce/eliminate acne-producing bacteria, benefiting patients through non-invasive inflammatory acne management.

Clinical Evidence

Bench testing only. Performance data confirmed irradiance levels at 4.6 inches are comparable to predicate devices and consistent with clinical study recommendations for P. acnes reduction. No new clinical trials were conducted for this submission; safety and efficacy are supported by the established performance of the predicate technology.

Technological Characteristics

Compact LED-based phototherapy lamp. Spectral output: 414 ± 5 nm (blue) and 633 ± 5 nm (red). Irradiance: 20 mW/cm² (blue) and 10 mW/cm² (red) at 4.6 inches. Includes positioning arm and firmware-controlled exposure timer. Connectivity: optional off-the-shelf electronic devices for data acquisition/storage.

Indications for Use

Indicated for the treatment of mild to moderate inflammatory acne vulgaris in patients requiring dermatological phototherapy by trained licensed practitioners.

Regulatory Classification

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.

Predicate Devices

• ClearLight, Phototherapy System, Model Cl 420 (K013623)
• BLU-U, Model 4710 (K031805)
• Omnilux Blue (K030883)
• Omnilux Red (K030426)

Submission Summary (Full Text)

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Care Electronics, Inc. 12/23/04

Dermillume Phototherapy Device 501(k)

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:

## K043575 1 of 2

## 『EB』《《 4》2005』

| Applicant & Submitter: | Care Electronics, Inc. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 4700 Sterling Dr., Suite D<br>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<br>Surgery and in Dermatology. Product code: GEX |
| Predicate Devices: | ClearLight, Phototherapy System, Model Cl 420 (K013623), BLU-<br>U, Model 4710 (K031805), Omnilux Blue (K030883), & Omnilux<br>Red (K030426) |
| Device Description: | The Dermillume Pro1000 device is a compact light source that<br>delivers high intensity narrow band blue and red light to the body<br>for the treatment of acne vulgaris. The light sources are narrow<br>wavelength LEDs that supply a spectral output of 414 ± 5 nm<br>(blue) and 633 ± 5 nm (red). The device supplies 20 and 10<br>mW/cm² for blue and red light, respectively, at 4.6 inches<br>distance from the skin surface.<br>The principal parts of the device are a light unit, positioning arm<br>and firmware timer to control duration of exposure. Additional off-<br>the-shelf electronic devices related to treatment data acquisition<br>and storage may be supplied as user options. |
| Intended Use: | The Dermillume Pro1000 phototherapy lamp is intended for<br>dermatological use by trained licensed practitioners, specifically<br>for the treatment of mild to moderate inflammatory acne vulgaris. |

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re Electronics, Inc.

Dermillume Phototherapy Device 501(k)

revised 2/10/2005

K043575

## 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.

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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 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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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

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**510(k) Number** K013575