MEDIFLASH AND ESTEFLASH

K093168 · Dermeo · ONF · May 21, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093168
• Device Name: MEDIFLASH AND ESTEFLASH
• Applicant: Dermeo
• Product Code: ONF · General, Plastic Surgery
• Decision Date: May 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEDIFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows: Intense Pulsed Light Energy/Wavelengths (420nm-1200nm) - The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations for Fitzpatrick Skin types I-III (Wavelengths - 515 - 1200 nm, or 500 -600 and 870 - 1200nm) - The treatment of benign pigmented epidermal and cutaneous lesions including scars and striae for Fitzpatrick Skin types I-III (Wavelengths -550- 1200 nm) - Treatment of inflammatory acne (acne vulgaris) for Fitzpatrick Skin types I-III (Wavelengths 420 - 1200 nm) - Removal of unwanted hair from all skin types and to effect stable long term or permanent* hair reduction through selective targeting of melanin in hair follicles (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 - 1200 nm). MEDIFLASH3 cannot be used for skin type VI. *Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime. The ESTHEFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows: - Removal of unwanted hair from all skin types and to effect stable long term or permanent* hair reduction through selective targeting of melanin in hair follicles. (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 - 1200 nm). ESTHEFLASH 3 cannot be used for skin type VI. *Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime.

Device Story

Intense Pulsed Light (IPL) system delivering non-ionizing radiation (400-1200 nm). Components: control console, display panel, power supply, cooling system, handpiece with detachable lamp/filter/mirror cartridge. Used in clinical settings by professionals for selective photothermolysis. Targets melanin in hair follicles or vascular/pigmented structures to treat lesions, acne, or remove hair. Output is light pulse; provider applies handpiece to skin surface. Benefits include non-invasive treatment of dermatological conditions and long-term hair reduction.

Clinical Evidence

Bench testing only. Compliance with UL 60101-1 (electrical safety) and FCC 60601-1-2 (electro-compatibility) standards. Performance data confirms system provides required output parameters for intended treatments.

Technological Characteristics

IPL system; 400-1200 nm spectral range. Components: control console, display panel, power supply (120V, 50-60Hz), cooling system, handpiece with detachable cartridge (lamp, mirror, filter). Standalone device. No software algorithm details provided.

Indications for Use

Indicated for dermatological/aesthetic treatments via selective photothermolysis. MEDIFLASH3: treats benign vascular/pigmented lesions, scars, striae, acne (Fitzpatrick I-III), and hair reduction (Fitzpatrick I-V). ESTHEFLASH3: hair reduction (Fitzpatrick I-V). Contraindicated for Fitzpatrick Skin type VI.

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

• Energist Ultra Variable Pulsed Light (K060234)

Submission Summary (Full Text)

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K093168

MAY 2 1 2010

# 510(k) Summary

SPONSOR

Company Name:

807.92(a)(1)

Vap 18, 189 Rue d'Aubervilliers Company Address Paris, France 75018

DERMEO

Telephone: Fax:

Contact Person:

PASCALE TANNOUS

[phone] [phone]

Summary Preparation Date: May 6, 2010

## DEVICE NAME

MEDIFLASH3 and ESTEFLASH3 Trade Name: Common/Usual Name: Intense Pulsed Light System Powered Laser Surgical Instrument Classification Name: Regulation Number: 878.4810 GEX Product Code: Device Class: II

# 807.92(a)(3)

807.92(a)(2)

PREDICATE DEVICE Legally Marketed Equivalent Device Company Product 510(k) # McCue Energist Ultra Variable Pulsed Light K060234 McCue Plc

#### DEVICE DESCRIPTION

The MEDIFLASH3 and ESTHEFLASH3 Intense Pulsed Light Device Systems are light based medical devices that deliver a flash of pulsed non-ionizing radiation within the spectral range covering 400 to 1200 nanometers. The system is designed to be compact and self contained and includes the following features:

- t Control console unit
- Display panel .
- Power supply .
- . Cooling system
- Hand piece with detachable cartridge with lamp, mirror and filter .

DEVICE INTENDED USE

# 807.92(a)(5)The

#### 807.92(a)(4)

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The MEDIFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows:

Intense Pulsed Light Energy/Wavelengths (420nm-1200nm)

- . The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations for Fitzpatrick Skin types I-III (Wavelengths - 515 - 1200 nm, or 500 -600 and 870 - 1200nm)
- The treatment of benign pigmented epidermal and cutaneous lesions including scars and . striae for Fitzpatrick Skin types I-III (Wavelengths -550- 1200 nm)
- Treatment of inflammatory acne (acne vulgaris) for Fitzpatrick Skin types I-III . (Wavelengths 420 - 1200 nm)
- Removal of unwanted hair from all skin types and to effect stable long term or . permanent* hair reduction through selective targeting of melanin in hair follicles. (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 – 1200 nm). MEDIFLASH3 cannot be used for skin type VI.

*Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime.

The ESTHEFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows:

- . Removal of unwanted hair from all skin types and to effect stable long term or permanent* hair reduction through selective targeting of melanin in hair follicles. (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 - 1200 nm). ESTHEFLASH 3 cannot be used for skin type VI.
*Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime.

#### COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

| Parameter | Dermeo MEDIFLASH3 and<br>ESTHEFLASH3 | Energist Ultra |
|--------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Intended use | Treatment of acne, vascular and<br>pigmented lesions and hair removal for<br>MEDIFLASH, hair removal only for<br>ESTHEFLASH | Treatment of acne, vascular and<br>pigmented lesions and hair<br>removal. |
| Design | • Control console unit<br>• Display panel | • Control console unit<br>• Display panel |

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| | Power supply Cooling system Handpiece with detachable cartridge with lamp, mirror and filter | Power supply Cooling system Handpiece w/ integrated switch, lamp, filter and glass coupling block |
|---------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| System Type | Intense Pulse Light System | Intense Pulse Light System |
| Power supply | 120V | 100V to 240V |
| Frequency of electrical current | 50-60Hz | 60/50hz |
| No of handpieces | 1 | 2 |

# NONCLINICAL AND CLINICAL TEST

# Testing of the Dermeo device was performed to UL 60101-1 -electrical safety and FCC 60601-1-2 - Electro-compatibility standards. Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters.

## CONCLUSION

#### 807.92(b)(3)

807.92(b)

The MEDIFLASH 3 and ESTHEFLASH 3 are substantially equivalent to the predicate device in intended use, design, mode of operation and performance characteristics

The MEDIFLASH 3 and ESTHEFLASH 3 introduce no new questions concerning the safety or effectiveness and is thus substantially equivalent to the predicate devices

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

MAY 2 1 2010

Dermeo % Smith Associates E. J. Smith 1468 Harwell Avenue Crofton, Maryland 21114

Re: K093168

Trade/Device Name: MEDIFLASH3 AND ESTHEFLASH3 Intense Pulsed Light System 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: ONF Dated: May 18, 2010 Received: May 18, 2010

Dear E. J. Smith:

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.

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

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Page 2 - E. J. Smith

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.

ncerely vours.

Carbeau Owens

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

510(k) Number (if known): K093168

Device Name: MEDIFLASH3 and ESTHEFLASH3 Intense Pulsed Light System

Indications for Use:

The MEDIFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows:

Intense Pulsed Light Energy/Wavelengths (420nm-1200nm)

- The treatment of benign cutaneous vascular lesions including port wine stains, . hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations for Fitzpatrick Skin types I-III (Wavelengths - 515 - 1200 nm, or 500 -600 and 870 - 1200nm)
- . The treatment of benign pigmented epidermal and cutaneous lesions including scars and striae for Fitzpatrick Skin types I-III (Wavelengths -550- 1200 nm)
- . Treatment of inflammatory acne (acne vulgaris) for Fitzpatrick Skin types I-III (Wavelengths 420 - 1200 nm)
- Removal of unwanted hair from all skin types and to effect stable long term or . permanent* hair reduction through selective targeting of melanin in hair follicles (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 - 1200 nm). MEDIFLASH3 cannot be used for skin type VI.

* Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime.

The ESTHEFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows:

- . Removal of unwanted hair from all skin types and to effect stable long term or permanent* hair reduction through selective targeting of melanin in hair follicles. (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 - 1200 nm). ESTHEFLASH 3 cannot be used for skin type VI.
*Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime.

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

Over-The-Counter Use (21 CFR 807 Subpart Ciry) - In

> (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number. K093168

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093168