(75 days)
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 RemovalHR ApplicatorHR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair RemovalHR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented Lesionsand 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 |
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.
The provided text describes the regulatory submission for the Ellipse Flex PPT dermatologic IPL system and asserts its substantial equivalence to predicate devices. However, it does not contain information about formal acceptance criteria, specific device performance against those criteria, or details of a study that proves the device meets such criteria (e.g., sample size, expert qualifications, ground truth, MRMC study, standalone performance, training set details).
Instead, the document focuses on:
- Identifying the device and its manufacturer.
- Describing its intended use and indications.
- Comparing its technical specifications and intended use to three predicate devices (Ellipse I²PL, StarLuxTM Pulsed Light System, and Lumenis Family of IPL).
- Concluding that the Ellipse Flex PPT is "substantially equivalent" to these predicate devices for the specified modules, applications, and intended uses.
The concept of "substantial equivalence" in a 510(k) submission means that the new device is as safe and effective as a legally marketed predicate device. This is often demonstrated through a comparison of technological characteristics, indications for use, and a declaration that it does not raise new questions of safety or effectiveness. The document itself is the submission detailing this comparison, rather than a report of a specific study proving acceptance criteria for the new device.
Therefore, most of the requested information cannot be extracted directly from this document as it pertains to a formal performance study against explicit acceptance criteria, which is not detailed here.
However, based on the provided text, here's what can be stated about the device and its comparison to predicates:
1. A table of acceptance criteria and the reported device performance
The document does not list specific numerical "acceptance criteria" for performance (e.g., a minimum efficacy rate or a maximum side effect rate) nor does it provide detailed "reported device performance" against such metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices based on shared technological characteristics and intended uses.
| Acceptance Criterion (Implicitly based on Predicate Equivalence) | Reported Device Performance (as presented for comparison) |
|---|---|
| Intended Use: Hair removal, treatment of benign pigmented/vascular lesions, treatment of inflammatory acne. (Matches predicate devices' scope where relevant). | Ellipse Flex PPT's Intended Use: Hair removal; Treatment of benign pigmented and vascular lesions; Treatment of inflammatory acne. (Stated as matching or being a subset of predicate uses). |
| Energy Spectrum: Comparable to predicate devices. | Ellipse Flex PPT: 400-950 nm (Compared to 555-950 nm for Ellipse I²PL, 400-1200 nm for StarLuxTM, 515-1200 nm for Lumenis). |
| Energy Output/Setting: Comparable to predicate devices. | Ellipse Flex PPT: 0-26 J/cm² (Identical to Ellipse I²PL, within range of StarLuxTM (Max 50 J/cm²), and Lumenis (10-60 J/cm²)). |
| Pulse Duration: Comparable to predicate devices. | Ellipse Flex PPT: 1.5-100 ms (Compared to 5-55 ms for Ellipse I²PL, 1-500 ms for StarLuxTM, 3-100 ms for Lumenis). |
| Applicator/Hand-piece Spot Size: Comparable to predicate devices. | Ellipse Flex PPT: 10 x 48 mm (Identical to Ellipse I²PL, within range of StarLuxTM (16x46mm, 12x28mm, 10x15mm), and Lumenis (9x9mm, 8x15mm, 15x35mm)). |
| Cooling Method: Similar to predicate devices to manage thermal effects. | Ellipse Flex PPT: Cooling handpiece by circulating water (Identical to Ellipse I²PL, comparable to contact cooling/integrated cooling in other predicates). |
| Safety and Effectiveness: Should not raise new issues of safety and effectiveness compared to predicate devices. | Conclusion: "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." |
2. Sample size used for the test set and the data provenance
Not applicable. This document does not describe a performance study with a test set that would have a sample size or data provenance details. The comparison is based on technical specifications and intended uses of the device and its predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document does not describe a performance study requiring expert ground truth establishment for a test set.
4. Adjudication method for the test set
Not applicable. This document does not describe a performance study requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an Intense Pulsed Light (IPL) system, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study related to "human readers improving with AI assistance" is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical IPL device, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This document does not describe a performance study that would establish ground truth for a diagnostic or treatment outcome using such methods. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior clearance, to which the new device is compared.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning device or algorithm that would involve a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not a machine learning device.
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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/SAgern Alle 112970 Hoersholm, DenmarkTel: + 45 4576 8808Fax: + 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 indermatology (per 21 CFR Part 878.4810). |
| Device classification: | Class II. |
| Product code: | GEX |
| Predicate devices legallymarketed to which DDDclaims equivalence: | Ellipse I2PL (K043255) manufactured by Danish DermatologicDevelopment A/S, Agern Alle 11, DK-2970 Hoersholm, Denmark.(Laser surgical instrument for use in general and plastic surgery andin dermatology (per 21 CFR Part 878.4810)).StarLuxTM Pulsed Light System (K041086) manufactured by PalomaMedical Technologies, Inc., 82 Cambridge Street, Burlington, MA01803.(Laser surgical instrument for use in general and plastic surgery andin dermatology (per 21 CFR Part 878.4810)).Lumenis Family of IPL (K030342) manufactured byLumenis Inc., 2400 Condensa Street, Santa Clara, CA 95051, USA.(Laser surgical instrument for use in general and plastic surgery andin dermatology (per 21 CFR Part 878.4810)). |
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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 RemovalHR ApplicatorHR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair RemovalHR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented Lesionsand 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 | StarLuxTMPulsed LightSystem | Lumenis Family ofIPL | |
|---|---|---|---|---|
| 510(k) referenceTechnology/Operation/Devicedescription | Current submissionIntense Pulsed Light(IPL)/broad spectrumlight/touch screenoperation. | K043255Intense Pulsed Light(IPL)/broad spectrumlight/touch screenoperation. | K041086Intense Pulsed Light(IPL)/broad spectrumlight and Nd: YAGlaser handle Lux1064 | K030342Intense Pulsed Light(IPL)/broad spectrumlight and Nd: YAGlaser handle. |
| Intended Use | Hair removal and thetreatment of benignpigmented andvascular lesions;Treatment ofInflammatory Acne. | Hair removal and thetreatment of benignpigmented andvascular lesions; | Treatment ofinflammatory acneand for the treatmentof benign pigmentedepidermal andcutaneous lesions,including warts, scarsand striae. | Surgical, aestheticand cosmeticapplications requiringselectivephotothermolysis andhemostasis of softtissue in the medicalspecialties of generaland 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 28mm, 10 x 15 mm | 9 x 9 mm, 8 x 15mm, 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 bycirculating water. | Cooling handpiece bycirculating water. | Contact coolingtechnology. | Skin coolingcomponentsintegrated in handpiece. |
| Deviceclassification | 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:
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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.
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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.
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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
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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 RemovalHR ApplicatorHR-S Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ⊖ |
| Hair RemovalHR-D Applicator | Hair (Thin, Normal, Thick) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Treatment of Benign Pigmented Lesionsand 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
§ 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.