(226 days)
Not Found
No
The summary describes a standard IPL device with no mention of AI or ML in its intended use, device description, or performance studies.
Yes
The device is indicated for medical treatments such as benign cutaneous vascular lesions, benign pigmented epidermal and cutaneous lesions, and inflammatory acne, which categorizes it as a therapeutic device.
No
The device description and intended use clearly state that it is an Intense Pulsed Light device for treatment of various dermatological conditions and hair removal, not for diagnosing them.
No
The device description explicitly states it is a "light based medical device" and lists hardware components such as a control console, display panel, power supply, cooling system, and hand piece. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for medical and aesthetic treatments applied directly to the patient's skin (e.g., treatment of vascular lesions, pigmented lesions, acne, hair removal). This involves interacting with the patient's body, not analyzing samples taken from the body.
- Device Description: The device description details a light-based system with a handpiece that delivers light to the patient. This aligns with a therapeutic or aesthetic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver light energy to the body for therapeutic and aesthetic effects.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ONF
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light Energy/Wavelengths (420nm-1200nm)
Anatomical Site
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
+33 (0) 1 72 98 98 72 +33 (0) 1 72 98 98 73
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)
1
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
ESTHEFLASH3 | Energist Ultra |
|--------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Intended use | Treatment of acne, vascular and
pigmented lesions and hair removal for
MEDIFLASH, hair removal only for
ESTHEFLASH | Treatment of acne, vascular and
pigmented lesions and hair
removal. |
| Design | • Control console unit
• Display panel | • Control console unit
• Display panel |
2
| 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
3
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 (800) 638-2041 or (301) 796-7100 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
5
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
6
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
the submit and the submit of the submit of the subscription of the subject of
Page of of
Neil RP Ogden for mxm.
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093168