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 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

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.

AI/ML Overview

The provided text describes a 510(k) summary for the Danish Dermatologic Development A/S (DDD) Ellipse I2PL dermatologic IPL system. This document is a premarket notification for a medical device trying to demonstrate substantial equivalence to previously cleared devices, rather than a study designed to prove acceptance criteria through clinical trial data. Therefore, many of the requested elements about acceptance criteria and study design are not applicable or explicitly stated as would be found in a clinical study report.

The primary "acceptance criteria" in a 510(k) submission is demonstrating substantial equivalence to a predicate device. The "study" proving this is essentially the comparison provided by the manufacturer.

Here's an analysis based on the information provided:

Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary focused on substantial equivalence, there are no explicit quantitative "acceptance criteria" presented in the sense of performance thresholds (e.g., "device must achieve X accuracy"). Instead, the "acceptance criterion" is the demonstration of substantial equivalence to predicate devices, which implies similar safety and effectiveness for the stated Indications for Use. The "reported device performance" is implicitly that it performs as safely and effectively as the predicate devices.

Acceptance Criteria (Implied by Substantial Equivalence Determination)	Reported Device Performance
Intended Use: Functionally identical to predicate devices.	Met: Ellipse I2PL (B02) is stated to have identical modules, applications, and intended uses to Ellipse IPL (A01), and identical and substantially equivalent technology, modules, applications, and intended uses to Ellipse Flex PPT.
Technological Characteristics: Similar to predicate devices, with no new issues of safety or effectiveness raised by differences.	Met: Comparison matrix shows similar technology (IPL/broad spectrum), energy output, pulse duration, applicator spot size, charge time, and cooling method. Differences in energy spectrum (400-950nm for B02/Flex PPT vs. 555-950nm for A01) are noted but deemed not to raise new safety/effectiveness issues.
Safety and Effectiveness: No significant differences in overall performance characteristics compared to predicate devices that would raise new questions of safety or effectiveness.	Met: Danish Dermatologic Development A/S (DDD) concludes that no significant differences exist and the added applications do not raise new issues of safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This document is a 510(k) summary for substantial equivalence, not a clinical study report. It does not contain data from an external test set with a defined sample size for performance evaluation.
Data Provenance: Not applicable. The "data" here refers to the specifications and intended uses of the device and its predicates, as presented by the manufacturer, rather than clinical data from a patient population.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. No external test set requiring expert-established ground truth is mentioned in this submission. The "ground truth" for demonstrating substantial equivalence rests on comparing the device's technical specifications and intended uses against already cleared predicate devices.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no test set requiring ground truth adjudication. The FDA's review process for 510(k) submissions involves regulatory experts evaluating the manufacturer's claims and comparison data.

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 diagnostic or assistance device. Therefore, no MRMC study or AI-related effectiveness metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (IPL system), not a standalone algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For a 510(k) clearance based on substantial equivalence, the "ground truth" is established by the previously cleared predicate devices and their established safety and effectiveness profiles. The manufacturer's submission effectively argues that the new device's characteristics align sufficiently with these predicates such that it poses no new questions of safety or effectiveness. There is no specific "expert consensus, pathology, or outcomes data" presented as ground truth for this specific device's performance beyond what was established for its predicates.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or an algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This device does not involve machine learning or an algorithm that requires a training set with established ground truth.

Summary

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K 060516

510(k) SUMMARY

MAY 15220066

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:	1 February 2006
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 I2PL.
Device Model number:	9ESL7228-B02.
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)).Ellipse Flex PPT (K052688) 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)).

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B. Description of Ellipse I2PL:

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.

C. Intended Use of Ellipse I2PL:

Ellipse I2PL 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. .

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	✓	✓	✓	✓	⊖	⊖
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

The Indications for Use for Ellipse if PL are:

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	Ellipse I²PL (B02)	Ellipse Flex PPT	Ellipse I²PL (A01)
510(k) reference	This submission	K052688	K043255
Technology/	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light
Operation/	(IPL)/broad spectrum	(IPL)/broad spectrum	(IPL)/broad spectrum
Device	light/touch screen	light/touch screen	light/touch screen
description	operation.	operation.	operation.
Intended Use	Hair removal and thetreatment of benignpigmented and	Hair removal and thetreatment of benignpigmented and	Hair removal and thetreatment of benignpigmented and
	vascular lesions;	vascular lesions;	vascular lesions;
	Treatment of	Treatment of	Treatment of
	Inflammatory Acne.	Inflammatory Acne.	Inflammatory Acne.
Energy spectrum	400-950 nm	400-950 nm	555-950 nm
Energy ouput/setting	0-26 J/cm²	0-26 J/cm²	0-26 J/cm²
Pulse duration	1,5-100 ms	1,5-100 ms	5-55 ms
Applicator/hand-piece spot size	10 x 48 mm	10 x 48 mm	10 x 48 mm
Charge time/repetion rate	1.5-2.0 s	1.5-2.0 s	1.5-2.0 s
Cooling method	Cooling handpiece bycirculating water.	Cooling handpiece bycirculating water.	Cooling handpiece bycirculating water.
Device	II; 21 CFR 878.4810,	II; 21 CFR 878.4810,	II; 21 CFR 878.4810,
classification	GEX	GEX	GEX

D. Comparison of Ellipse It PL to predicate devices:

Conclusion:

The Ellipse I2PL (B02) has been evaluated and compared to its predicate systems (to Ellipse If PL (A01) (manufactured by DDD), and Ellipse Flex PPT (manufactured by DDD)). The Ellipse I2PL (B02) system, as far as the identical modules, applications and intended uses are concerned, are identical to Ellipse IPL (A01) and identical and substantially equivalent to the Ellipse Flex PPT with regards to technology as well as modules, applications and intended uses.

Based on this analysis of the overall performance characteristics of the mentioned predicate devices Danish Dermatologic Development A/S (DDD) concludes that no significant differences exist. The applications added to the original Ellipse IPL system does not raise new issues of safety and effectiveness and is substantially equivalent to the monthoned predicate devices.

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Image /page/3/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 four stylized human figures connected at the shoulders, with their arms raised. The figures are depicted in a simple, abstract manner, and the overall design is clean and professional.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 15 2006

Danish Dermatologic Development A/S c/o Mr. Ole Kofod QA/RA Manager Agern Alle 11 2970 Hoersholm, Denmark

Re: K060516

Trade/Device Name: Ellipse I2PL 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: February 1, 2006 Received: February 27, 2006

Dear Mr. Kofod:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Ole Kofod

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. 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 marketed 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) number:	K060516
----------------	---------

Ellipse I2PL Device Name:

Indications for 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 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

Prescription Use X (Part 21CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

.gmall

(Division Sign-O Division of General, Restorative. and Neurological Devices

510(k) Number_ko60516

Regulation Number and Section

§ 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.