DPL NUVE

K101382 · Led Technologies, LLC · OHS · Nov 9, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101382
• Device Name: DPL NUVE
• Applicant: Led Technologies, LLC
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Nov 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Indicated as an over-the-counter phototherapy device for the treatment of mild to moderate acne.

Device Story

dpl® Nüve is a lightweight, handheld LED phototherapy device with interchangeable heads. Blue LED head (415 nm) treats mild to moderate inflammatory acne; red (625 nm) and purple/infrared (830 nm) heads treat periorbital wrinkles. Device includes internal electronics, cooling fan, and automatic shut-off safety feature. Operated by patient in home setting. Light energy application targets skin tissue to reduce wrinkles and treat acne. Safety and effectiveness established via nonclinical testing.

Clinical Evidence

Bench testing only. Device safety demonstrated through compliance with IEC 60601-1, EN 60601-1-2, and EN 60601-2-22 standards. Biocompatibility of patient contact materials confirmed via ISO 10993 testing.

Technological Characteristics

Handheld LED device with interchangeable heads. Wavelengths: 415 nm (blue), 625 nm (red), 830 nm (infrared). Features internal cooling fan and automatic shut-off safety mechanism. Complies with IEC 60601-1, EN 60601-1-2, and EN 60601-2-22. Patient contact materials tested per ISO 10993.

Indications for Use

Indicated for treatment of periorbital wrinkles and mild to moderate inflammatory acne in patients using the device as an over-the-counter phototherapy product.

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

• Omnilux New U
• Tanda Skin Care

Submission Summary (Full Text)

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K101382

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## 510(k) Summary

Submitted by:

Contact Person:

LED Technologies, LLC 133 County Road 17 Elizabeth, CO 80107 USA

Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 USA 303-530-3279 [e-mail]

Date Prepared:

5-13-2010

Device Trade Name:

dpl® Nüve

LED lamp

878.4810

Common Name:

Regulation Number:

Classification Name:

Intended Use:

Technological Characteristics:

Substantial Equivalence:

Infrared lamp OHS: light-based over-the-counter wrinkle reduction GEX: powered laser surgical instrument (for acne treatment)

Intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Indicated as an over-the-counter phototherapy device for the treatment of mild to moderate acne.

The dpl® Nüve is a lightweight, handheld, light emitting diode (LED) device with interchangeable heads which emit light energy. A blue LED head in the 415 nm spectrum is used in treatment for mild to moderate inflammatory acne. A red head at 625 nm and a purple head (infrared) in the 830 nm spectrum are used in combination for reduction of periorbital wrinkles. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature

The device is substantially equivalent in function and technology To the Omnilux New U for periorbital wrinkle treatment and the Tanda Skin Care product for treatment of acne. Conclusions drawn from the nonclinical and clinical tests demonstrate that the

NOV - 9 2010

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device is as safe and effective as the legally marketed predicate devices.

Test Data:

The dpl® Nüve has been demonstrated safe by testing and meeting IEC 60601-1, EN 60601-1-2, and EN 60601-2-22. Patient contact materials are demonstrated safe under ISO 10993 testing. The dpl® Nüve does not raise new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three human figures in profile superimposed on the eagle's body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

LED Technologies, LLC % L. W. Ward and Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80107

NOV - 9 2010

Re: K101382

Trade/Device Name: dpl® Nuve Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OHS, GEX Dated: November 01, 2010 Received: November 03, 2010

Dear Mr. Ward:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. Lewis Ward

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Milburn

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation . Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

/oB82

510(k) Number (if known):

Device Name: dpl® Nuve

NOV - 9 2010

Indications for Use:

Intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Indicated as an over-the-counter phototherapy device for the treatment of mild to moderate acne.

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-the-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

NehRe Order for nxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101382