(75 days)
Not Found
No
The provided text describes a standard Intense Pulsed Light (IPL) system with control electronics and software for managing treatment parameters. There is no mention of AI, ML, image processing for analysis, or any data-driven learning components. The device description and intended use are consistent with traditional IPL technology.
Yes
The device is described as treating various medical conditions such as benign pigmented lesions, benign vascular lesions, telangiectasias, port wine stains, and inflammatory acne, which falls under the definition of a therapeutic device.
No
The device description and intended uses clearly state its purpose is for treatment (hair removal, treatment of benign pigmented/vascular lesions, inflammatory acne), not for diagnosis.
No
The device description explicitly states that the system consists of a console containing a power unit and control electronics, in addition to the control and display panel including software. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the Ellipse Flex PPT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The intended uses and indications for use clearly describe treatments performed directly on the patient's skin (hair removal, treatment of skin lesions, acne). IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device description details an Intense Pulsed Light (IPL) system used for direct application to the skin. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-related information: The document does not contain any information typically found in submissions for IVD devices, such as details about sample types, analytical methods, or performance metrics related to diagnostic accuracy.
Therefore, the Ellipse Flex PPT is a therapeutic device used for dermatological treatments, not an IVD device.
N/A
Intended Use / Indications for 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. .
Product codes
GEX
Device Description
D. Description of Empor I was I r ed 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light (IPL)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 12 2005
K052688 1 of 4
510(k) SUMMARY
Danish Dermatologic Development A/S (DDD) Ellipse Flex PPT dermatologic IPL system.
This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.87(h) and Part 807.92.
A. Contact information and device identification:
| Date of the summary: | 08 November 2005 |
|---|---|
| Submitted by/manufacturer: | Danish Dermatologic Development A/S |
| Agern Alle 11 | |
| 2970 Hoersholm, Denmark | |
| Tel: + 45 4576 8808 | |
| Fax: + 45 4517 6851 | |
| Contact person: | Ole Kofod |
| Device Trade Name: | Ellipse Flex PPT. |
| Device Model number: | 9ESF7255. |
| Common Name: | Intense Pulsed Light (IPL) system. |
| Classification name: | Laser surgical instrument for use in general and plastic surgery and in |
| dermatology (per 21 CFR Part 878.4810). | |
| Device classification: | Class II. |
| Product code: | GEX |
| Predicate devices legally | |
| marketed to which DDD | |
| claims equivalence: | Ellipse I2PL (K043255) manufactured by Danish Dermatologic |
| Development A/S, Agern Alle 11, DK-2970 Hoersholm, Denmark. | |
| (Laser surgical instrument for use in general and plastic surgery and | |
| in dermatology (per 21 CFR Part 878.4810)). | |
| StarLuxTM Pulsed Light System (K041086) manufactured by Paloma | |
| Medical Technologies, Inc., 82 Cambridge Street, Burlington, MA |
(Laser surgical instrument for use in general and plastic surgery and
in dermatology (per 21 CFR Part 878.4810)).
Lumenis Family of IPL (K030342) manufactured by
Lumenis Inc., 2400 Condensa Street, Santa Clara, CA 95051, USA.
(Laser surgical instrument for use in general and plastic surgery and
in dermatology (per 21 CFR Part 878.4810)). |
1
K052688 2 of 4
B. Description of Ellipse Flex PPT:
D. Description of Empor I was I r ed 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.
C. Intended Use of Ellipse Flex PPT:
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 | |||||||
| HR Applicator | |||||||
| HR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair Removal | |||||||
| HR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented Lesions | |||||||
| 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 |
2
K052488 3 of 4
| | Ellipse Flex PPT | Ellipse I²PL | StarLuxTM
Pulsed Light
System | Lumenis Family of
IPL |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) reference
Technology/
Operation/
Device
description | Current submission
Intense Pulsed Light
(IPL)/broad spectrum
light/touch screen
operation. | K043255
Intense Pulsed Light
(IPL)/broad spectrum
light/touch screen
operation. | K041086
Intense Pulsed Light
(IPL)/broad spectrum
light and Nd: YAG
laser handle Lux
1064 | K030342
Intense Pulsed Light
(IPL)/broad spectrum
light and Nd: YAG
laser handle. |
| Intended Use | Hair removal and the
treatment of benign
pigmented and
vascular lesions;
Treatment of
Inflammatory Acne. | Hair removal and the
treatment of benign
pigmented and
vascular lesions; | Treatment of
inflammatory acne
and for the treatment
of benign pigmented
epidermal and
cutaneous lesions,
including warts, scars
and striae. | Surgical, aesthetic
and cosmetic
applications requiring
selective
photothermolysis and
hemostasis of soft
tissue in the medical
specialties of general
and plastic surgery,
and dermatology. |
| Energy spectrum | 400-950 nm | 555-950 nm | 400-1200 nm | 515-1200 nm |
| Energy ouput/
setting | 0-26 J/cm² | 0-26 J/cm² | Max 50 J/ cm² | 10-60 J/ cm² |
| Pulse duration | 1,5-100 ms | 5-55 ms | 1-500 ms | 3-100 ms |
| Applicator/hand-
piece spot size | 10 x 48 mm | 10 x 48 mm | 16 x 46 mm, 12 x 28
mm, 10 x 15 mm | 9 x 9 mm, 8 x 15
mm, 15 x 35 mm |
| Charge time/
repetion rate | 1.5-2.0 s | 1.5-2.0 s | Up to 2 Hz. | 1 s |
| Cooling method | Cooling handpiece by
circulating water. | Cooling handpiece by
circulating water. | Contact cooling
technology. | Skin cooling
components
integrated in hand
piece. |
| Device
classification | II; 21 CFR 878.4810,
GEX | II; 21 CFR 878.4810,
GEX | II; 21 CFR 878.4810,
GEX | II; 21 CFR 878.4810,
GEX |
D. Comparison of Ellipse Flex PPT to predicate devices:
3
K052688 40+4
Conclusion:
All applications of the Ellipse I2PL (DDD) are included in the Ellipse Flex PPT. StarLux™ (Palomar Medical Technologies, Inc.) has a broader range of applications than Ellipse Flex PPT, the intended use for Ellipse Flex PPT is covered by the StarlLux™ Lumenis One of the Lumenis Family of IPL (Lumenis, Inc.) has a broader range of applications than Ellipse Flex PPT as Lumenis One includes a Laser module for vascular treatment applications in addition to the IPL modules. Ellipse Flex PPT does not employ a Laser module, only IPL. Eilipse Flex PPT thus utilizes a subset of the Lumenis One technologies.
The Ellipse Flex PPT has been evaluated and compared to the above systems and to their application modules (to Ellipse I2PL (DDD), Lumenis One (Lumenis, Inc.) ,and StarLux™ (Palomar Medical Technologies, Inc.). The Ellipse Flex PPT system, as far as the identical modules, applications and intended uses are concerned, are judged to be identical to Ellipse I-PL and substantially equivalent to the Lumenis One (Lumenis, Inc.) ,and StarLux™ (Palomar Medical Technologies, Inc.) (predicate devices cleared in K043255, K041086 and, K030342 respectively)
Based on this analysis of the overall performance characteristics of the mentioned predicate devices Danish Dermatologic Development A/S believes that no significant differences exist. The Ellipse Flex PPT system should not raise new issues of safety and effectiveness and is judged to be substantially equivalent to the mentioned predicate devices.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2005
Ole Kofod QA/RA Manager Danish Dermatologic Development A/S Agern Alle 11 DK-2970 Horsholm Denmark
Re: K052688 Trade/Device Name: Ellipse Flex PPT, Model 9ESF7255 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: November 5, 2005 Received: November 9, 2005
Dear Ole Kofod:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bootion of the device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the energing hate of the Medical Device Amendments, or to devices that problem of May 26, 1770, and chance ask the Federal Food, Drug, and Cosmetic Ilave been receasinou in acceraroval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, matice the detect ise, sabject we annual registration, listing of devices, good controls provibitions or entabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your de rice is olassified in the major regulations affecting your device can be may of subject to sam adantines, 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 I lease be advised mate 1 27 i in that your device complies with other requirements of the Act or any FDA has made a determination administered by other Federal agencies. You must comply with all r cacial statutes and 16g. and 10g, but not limited to: registration and listing (21 CFR Part 807); the 7ter 31equirements, merading, cannfacturing practice requirements as set forth in the quality labeling (21 CFR Part 801), good names 20); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2 - Ole Kofod
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 premated 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
barbary Brechner
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Abbreviated - 510(k) Notification - Corr. 1
Ellipse Flex PPT Device Name:
Indications for Use:
The Intended Use for Ellipse Flex PPT is: 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 | |||||||
| HR Applicator | |||||||
| HR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair Removal | |||||||
| HR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented Lesions | |||||||
| 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 |
Cale Hood
(Signature)
Ole Kofod
(Typed Name)
4-11-2005
(Date)
K052688
(Premarket Notification 510(k) Number)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
K0526000 1 of 1
Barbara Buchenus for Nixon
estorative. Division of Ge and Neurological De
510(k) Number K052688