(92 days)
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No
The provided text describes a standard Intense Pulsed Light (IPL) system with a console, power unit, control electronics, and applicators. There is no mention of AI, ML, image processing, or any data-driven algorithms for treatment planning or execution. The description focuses on the hardware and the light energy generation for specific dermatological applications.
Yes
The device is described for "treatment of benign pigmented lesions" and "benign vascular lesions," which are therapeutic applications, and its description explicitly states it is "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."
No.
The device is described as an Intense Pulsed Light (IPL) system intended for treatment (hair removal and treatment of benign pigmented and vascular lesions), not for diagnosis.
No
The device description explicitly states the system consists of a console containing a power unit, control electronics, and applicators/hand-pieces that generate light energy. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the Ellipse I2PL device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The intended use and indications clearly state that the device is used for treating conditions on the skin (hair removal, benign pigmented lesions, benign vascular lesions). IVDs are used to diagnose diseases or conditions by examining samples taken from the body (like blood, urine, tissue).
- Device Description: The description details a system that generates light energy for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
The Ellipse I2PL is a therapeutic device used in dermatology, specifically utilizing Intense Pulsed Light (IPL) for various skin treatments.
N/A
Intended Use / Indications for 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 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 | ✓ | ✓ | ✓ | ✓ | ⊖ | ⊖ |
| Note: Patients with darker Fitzpatrick Skin Types (4 or above) or who are suntanned should always be treated with extra care and attention. | |||||||
| Key: ✓ Allowed; ⊖ Not Allowed |
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K024093; K020839, K030897, K020453
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.
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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).
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§ 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
510(k) SUMMARY
Danish Dermatologic Development A/S (DDD) Ellipse I2PL 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: | 11 February 2005 |
|---|---|
| Submitted by/manufacturer: | Danish Dermatologic Development A/S |
| Agern Alle 11 | |
| 2970 Hoersholm, Denmark | |
| Tel: + 45 4576 8808 | |
| Fax: + 4517 6851 | |
| Contact person: | Ole Kofod |
| Device Trade Name: | Ellipse I2PL. |
| Device Model number: | 9ESL7228. |
| 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: | IPL™ Quantum (K024093; K020839) 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)). | |
| Skin Station™ (K030897) manufactured by Radiancy Inc., 40 | |
| Ramland Road South, Suite 10, Orangeburg, New York 10962,USA. | |
| (Laser surgical instrument for use in general and plastic surgery and | |
| in dermatology (per 21 CFR Part 878.4810)). | |
| EsteLux™ (K020453) manufactured by Palomar Medical | |
| Technologies, Inc., 82 Cambridge Street, Burlington, MA 01803. | |
| (Laser surgical instrument for use in general and plastic surgery and | |
| in dermatology (per 21 CFR Part 878.4810)). |
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