The Or-Light® is a non-coherent light-based device intended to carry out dermatologic and aesthetic care. It is meant to be handled by competent professionals trained in intense pulsed light technology.

Two different applicators can be used on the Or-Light® device.

The HR applicator (610-1000 nm) is indicated for:

Hair Removal for skintype I to IV
The SR applicator (400-1000 nm) is indicated for
Benign pigmentary lesions for skintype I to III
Benign vascular lesions for skintype I to III
Inflammatory acne treatment for skintype I to III

Device Description

The Or-Light® is a non-coherent light based device intended to carry out dermatologic and aesthetic care on patients by skin professional.

The system consists of a console containing a power unit controlled by electronic and software. Setting is selected by the operator through a display panel (touch screen).

Light energy for the treatment is generated by the applicators connected to the device. Two type of applicator can be connected, one at a time. The applicators are in the waveband of 400 nm - 1000 nm and 610 nm - 1000 nm.

The applicator is cooled by a closed water cooling circuit built in the device.

AI/ML Overview

This 510(k) summary does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. The document primarily asserts substantial equivalence to predicate devices, stating that differences in specifications "do not result in different performances or raise any new question of safety or effectiveness." It mentions "clinical data" generally but does not provide specific details about acceptance criteria, study design, sample sizes, or expert qualifications.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here's what can be inferred and what is missing:

Overview of Acceptance Criteria and Device Performance

The document does not explicitly define specific "acceptance criteria" (e.g., minimum sensitivity, specificity, accuracy targets) for its performance. Instead, it relies on the concept of substantial equivalence to predicate devices. The implicit "acceptance criterion" is that the Or-Light® performs safely and effectively for its stated indications, similarly to the predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and Effectiveness for:
Hair Removal (skintype I-IV)	"clinical data demonstrate that the device can be used effectively and safely by a trained skin professional."
Benign pigmentary lesions (skintype I-III)	"clinical data demonstrate that the device can be used effectively and safely by a trained skin professional."
Benign vascular lesions (skintype I-III)	"clinical data demonstrate that the device can be used effectively and safely by a trained skin professional."
Inflammatory Acne (skintype I-III)	"clinical data demonstrate that the device can be used effectively and safely by a trained skin professional."
No new safety or effectiveness questions compared to predicates.	"The differences in the specification of the Or-Light® and the predicate devices do not result in different performances or raise any new question of safety or effectiveness."

Study Details (As much as can be extracted/inferred):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document vaguely refers to "clinical data" without providing any details on study design, sample size, or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- No information provided. Ground truth establishment, if any, for the "clinical data" is not described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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/Not mentioned. This device is an Intense Pulsed Light (IPL) system, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device for treatment, not an algorithm. Its performance is inherent to the device's physical operation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified. The "clinical data" would presumably involve patient outcomes related to the indicated treatments, but the specific nature of the data and how success was defined as ground truth is not elaborated.
The sample size for the training set:
- Not applicable/Not specified. This is not an AI/machine learning device that requires a "training set" in the typical sense. Any "training" would refer to the development and testing phases of the physical device and its settings, for which specific sample sizes are not provided.
How the ground truth for the training set was established:
- Not applicable/Not specified. As above, a "training set" in the AI sense is not applicable. The development of the device would involve engineering specifications and testing to meet those, but these are not described as "ground truth."

Summary

{0}------------------------------------------------

090724 Page 1/2

510(k) SUMMARY

Or-Light®

YPERION dermatologic Intense Pulsed Light system

Submitter's name, address, telephone number, contact person and Date

YPERION Technology SAS 76-78 Av des Champs Elysées 75008 Paris France 00 33 1 56 89 10 40 Telephone : 00 33 1 45 27 68 33 Fax :

Pascal Danet Contact person : General Manager 2. rue Beethoven 75016 Paris France 00 33 1 56 89 10 40 Telephone : 00 33 1 45 27 68 33 Fax : pdanet@ yperion.fr Email :

February 26, 2009 Date prepared:

Name of Device

Device Trade Name: Or-Light® System YPL08011 Model: Intense Pulsed light System for cosmetic and dermatologic treatments Common use: Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Product code : GEX Regulation Number : 878 4810

Predicated device

Yperion Technology : L600®; K030480 Danish Dermatologic Developpement (as DDD) : Ellipse IPPL ; K060516

System Description

The Or-Light® is a non-coherent light based device intended to carry out dermatologic and aesthetic care on patients by skin professional.

The system consists of a console containing a power unit controlled by electronic and software. Setting is selected by the operator through a display panel (touch screen).

Light energy for the treatment is generated by the applicators connected to the device. Two type of applicator can be connected, one at a time. The applicators are in the waveband of

OCT - 7 2009

{1}------------------------------------------------

090572f Page 2/2

400 nm 1000 nm 트
보 610 nm - 1000 nm.

The applicator is cooled by a closed water cooling circuit built in the device.

Intended Use

The Or-Light® is designed to perform :

Hair Removal for skintype I to IV ■
Benign pigmentary lesions for skintype I to III 디
Benign vascular lesions for skintype I to III .
Treatment of inflammatory Acne for skintype I to III 트

Comparing technical characteristics/ Performance Data

The differences in the specification of the Or-Light® and the predicate devices do not result in different performances or raise any new question of safety or effectiveness. The clinical data demonstrate that the device can be used effectively and safely by a trained skin professionnal.

Summary

Based on the foregoing, we believe that the Or-Light® is substantially equivalent to the legally marketed predicate devices, the L600® and the Ellipse I2PL.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles three wavy lines or strokes, which is the department's logo. The logo is positioned to the right of the text, creating a balanced composition.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

YPERION Technology % Pascal Danet General Manager 2, rue Beethoven 75016 Paris France

OCT - 7 2009

Re: K090724

Trade/Device Name: System Or-Light® Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II

Product Code: ONF Dated: September 18, 2009 Received: September 22, 2009

Dear Pascal Danet:

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 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): medical device reporting (reporting of medical

{3}------------------------------------------------

Page 2 - Pascal Danet

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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

Enclosure

{4}------------------------------------------------

Indication for use

Applicant :

YPERION TECHNOLOGY SAS

510(k) Number (if known): K090724

Device Name:

System Or-Light®

Indications of Use:

Two different applicators can be used on the Or-Light® device.

The HR applicator (610-1000 nm) is indicated for:

Hair Removal for skintype I to IV ■
The SR applicator (400-1000 nm) is indicated for
Benign pigmentary lesions for skintype I to III ■
Benign vascular lesions for skintype I to III 트
Inflammatory acne treatment for skintype I to III 피

And/Or X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Oakes-Forman

(Division Sign-One), Orihopedic, Division of Surgices Division of Sere
and Restorative Devices

510(k) Number K090724

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.