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510(k) Data Aggregation
K Number
K060516Device Name
ELLIPSE 12PL, MODEL 9ESL7228
Manufacturer
DANISH DERMATOLOGIC DEVELOPMENT A/S
Date Cleared
2006-05-15
(77 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DANISH DERMATOLOGIC DEVELOPMENT A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intended Use for Ellipse I²PL is:
Ellipse IPPL is intended for use in dermatology:
- Hair removal (permanent hair reduction). .
- Treatment of benign pigmented lesions (including, but not limited to solar . lentigines, ephilides, mottled pigmentation) and benign vascular lesions (including but not limited to diffuse redness, telangiectasias, port wine stains).
- Treatment of inflammatory acne. .
The Indications for Use for Ellipse I-PL are:
| Application | Treatment Variable | Fitzpatrick Skin Type | | | | | |
|----------------------------------------------------------------------|-----------------------------------|-----------------------|---|---|---|---|---|
| | | 1 | 2 | 3 | 4 | 5 | 6 |
| Hair Removal<br>HR Applicator<br>HR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair Removal<br>HR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented Lesions<br>and Benign Vascular Lesions | Pigmentation / Vessel Size | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Treatment of Telangiectasias | Vessel size (Thin, medium, thick) | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Treatment of Port Wine Stains | Color (Red, blue) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Treatment of Individual Pigmented Lesions | Pigment Color | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Treatment of Inflammatory Acne | | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Key: ✓ Allowed; ⊖ Not Allowed | | | | | | | |
Device Description
Ellipse I2PL is an Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair and for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores, diffuse redness, and for the treatment of telangiectasias, port wine stains and inflammatory acne in the area of dermatology.
The system consists of a console containing power unit and control electronics with control and display panel including software.
Applicators/hand-pieces are connected to the system in order to generate light energy for treatment in the waveband 400 nm - 950 nm.
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K Number
K052688Device Name
ELLIPSE FLEX PPT, MODEL 9ESF7255
Manufacturer
DANISH DERMATOLOGIC DEVELOPMENT A/S
Date Cleared
2005-12-12
(75 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DANISH DERMATOLOGIC DEVELOPMENT A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ellipse Flex PPT is intended for use in dermatology:
- Hair removal (permanent hair reduction). .
- Treatment of benign pigmented lesions (including, but not limited to solar lentigines, . ephilides, mottled pigmentation) and benign vascular lesions (including but not limited to diffuse redness, telangiectasias, port wine stains).
- Treatment of inflammatory acne. .
The Indications for Use for Ellipse Flex PPT are:
| Application | Treatment Variable | Fitzpatrick Skin Type | | | | | |
|----------------------------------------------------------------------|-----------------------------------|-----------------------|---|---|---|---|---|
| | | 1 | 2 | 3 | 4 | 5 | 6 |
| Hair Removal<br>HR Applicator<br>HR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair Removal<br>HR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented Lesions<br>and Benign Vascular Lesions | Vessel size/Pigmentation | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Treatment of Telangiectasias | Vessel size (Thin, medium, thick) | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Treatment of Port Wine Stains | Color (Red, blue) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Treatment of Individual Pigmented Lesions | Pigment Color | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Treatment of Inflammatory Acne | | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Key: ✓ Allowed; ⊖ Not Allowed | | | | | | | |
Device Description
Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair; for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores, diffuse for trounnell of the treatment of telangiectasias, port wine stains and inflammatory acne in the area of dermatology.
The system consists of a console containing power unit and control electronics with control and display panel including software.
paint moduling bothware. waveband 400 nm - 950 nm.
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K Number
K043255Device Name
ELLIPSE LIGHT SPT
Manufacturer
DANISH DERMATOLOGIC DEVELOPMENT A/S
Date Cleared
2005-02-24
(92 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DANISH DERMATOLOGIC DEVELOPMENT A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intended Use for Ellipse I2PL is:
Ellipse 12PL. is intended for use in dermatology.
- · Hair removal (permanent hair reduction).
- · Treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (diffuse redness).
The Indications for Use for Ellipse I2PL are:
| Application | Treatment Variable | Fitzpatrick Skin Type | | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------|---|---|---|---|---|
| | | 1 | 2 | 3 | 4 | 5 | 6 |
| Hair Removal<br>HR Applicator<br>HR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair Removal<br>HR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented Lesions<br>And Benign Vascular Lesions | Pigmentation | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Note: Patients with darker Fitzpatrick Skin Types (4 or above) or who are suntanned should always be treated with extra care and<br>attention. | | | | | | | |
| Key: ✓ Allowed; ⊖ Not Allowed | | | | | | | |
Device Description
Ellipse If PL is an Intense Pulsed Light (IPL) system used for long-term removal of unwanted hair and for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores and diffuse redness in the area of dermatology.
The system consists of a console containing power unit and control electronics with control and display panel including software.
Applicators/hand-pieces are connected to the system in order to generate light energy for treatment in the waveband 555 nm - 950 nm.
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