The Lumenis Family of Intense Pulsed-Light (IPL) systems and combination IPL/Nd:YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:

Intense Pulsed Light Energy / Wavelengths (515 - 1200 nm):

The treatment of tattoos and benign pigmented epidermal and cutaneous lesions * including warts, scars and striae;
- The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-VI through selective targeting of melanin in hair follicles;

Nd:YAG Laser Wavelength (1064 nm):

- The coagulation and hemostasis of vascular lesions and soft tissue, including:
  - - Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg;
- The non-ablative treatment of facial wrinkles.

The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:

- Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
Reduce discomfort during and/or associated with light or laser treatment; *
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyperand/or hypopigmentation;
- Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
- Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Device Description

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are comprised of the following main components:

- A light/laser system console (including software and control electronics);
A control and display panel; and *
- One or more attached hand-piece(s), which may have integrated skin cooling components.

AI/ML Overview

This is a pre-market notification for a laser system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies (such as MRMC, standalone performance, ground truth, and sample sizes) is largely not applicable in the context of AI/ML device evaluation.

Here's a breakdown of why this information isn't present in the provided text for an AI/ML context:

Device Type: The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are medical devices that physically interact with tissue for surgical, aesthetic, and cosmetic applications. They are not software-based AI/ML devices that provide diagnostic or prognostic insights.
Approval Process: The document is a 510(k) submission, indicating a substantial equivalence pathway. This pathway compares the new device to existing legally marketed predicate devices to demonstrate that it is as safe and effective. It does not typically involve the rigorous performance metric evaluations (like sensitivity, specificity, AUC) associated with AI/ML devices.
"Acceptance Criteria" in this context: For this type of device, "acceptance criteria" primarily refer to demonstrating that the device's technical specifications and performance (e.g., fluence, pulse rate, spot size) are comparable to predicate devices and that clinical data supports its safety and effectiveness for its intended use. There are no "reported device performance" metrics in the sense of AI/ML model output.

However, I can provide the available information relevant to the device's evaluation, reinterpreting "acceptance criteria" and "study" for this non-AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance (Reinterpreted for a Laser System)

Since this is a 510(k) for a laser system, the "acceptance criteria" are implied by its comparison to predicate devices across various technical and functional specifications, and the "reported device performance" is its demonstrated capability to meet those same specifications and achieve the intended clinical effects.

Category	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (Lumenis Family IPL/Nd:YAG)
Intended Use	Substantially equivalent or within the scope of predicate devices' intended use (Photocoagulation, photothermolysis, and hemostasis in surgical, aesthetic, cosmetic applications; specific indications like hair reduction, vascular lesions, pigmented lesions, facial wrinkles, and pain/discomfort reduction with chilling).	Matches or Expands Upon Predicates: Photocoagulation, photothermolysis, and hemostasis of soft tissue in general and plastic surgery, and dermatology. Specific indications (some expanded from predicates): treatment of tattoos, benign pigmented lesions, warts, scars, striae, benign cutaneous vascular lesions, unwanted hair removal (stable long-term/permanent reduction), coagulation/hemostasis of vascular lesions/soft tissue (telangiectasias, reticular veins), non-ablative treatment of facial wrinkles.
Device Description	IPL and/or Nd:YAG laser combination or components.	IPL and IPL/Nd:YAG combination.
Output Energy Type	Coherent and non-coherent light.	Coherent and non-coherent light.
Energy Configuration	Wavelengths typically 515-1200 nm for IPL, 1064 nm for Nd:YAG.	515-1200 nm (IPL), 1064 nm (Nd:YAG).
Fluence	Fluence levels comparable to or within ranges of predicate devices.	Up to 150 J/cm² (comparable to or within range of predicates, e.g., IPL Quantum/VascuLight same, Lyra™ up to 250 J/cm², GentleYAG 10-70 J/cm²).
Pulse Duration	Pulse durations comparable to or within ranges of predicate devices.	2 to 16 ms (to 48 ms triple pulsed) (comparable to or within range of predicates, e.g., IPL Quantum/VascuLight same, Lyra™ 10-50 ms, GentleYAG 3 ms).
Pulse Rate	Pulse rates comparable to or within ranges of predicate devices.	0.33 Hz (same as IPL Quantum/VascuLight).
Spot Size	Spot sizes comparable to or within ranges of predicate devices.	6 mm (same as IPL Quantum/VascuLight, different from Lyra™ and GentleYAG).
Beam Delivery	Cooling Hand-piece (or similar mechanisms as predicates like fiber with cooling).	Cooling Hand-piece (same as IPL Quantum/VascuLight, similar to Lyra™ fiber w/cooling and GentleYAG lens-coupled fiber with hand-piece).
Clinical Efficacy & Safety	Demonstrated safety and effectiveness for stated indications, often through clinical data or literature reviews supporting the chosen parameters.	Clinical data provided: "Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective, when indicated in specific applications in the medical specialties of general and plastic surgery, and dermatology." This data presumably supports the device's ability to achieve the stated selective photothermolysis, photocoagulation, and hemostasis for the given indications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective..."
No specific sample size, data provenance, or retrospective/prospective nature of the clinical data is provided in this summary. This level of detail is typically found in the full study reports, not necessarily in the high-level 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For a laser system, "ground truth" isn't established by experts interpreting outputs in the way it is for AI/ML diagnostic tools. The "truth" would be the observed clinical outcome (e.g., hair reduction, lesion clearance, wrinkle reduction) directly from the treatment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI/ML performance evaluation, which is not relevant here.

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 is a laser treatment device, not an AI diagnostic/assistant tool. MRMC studies are for evaluating scenarios where humans are interpreting outputs (e.g., medical images) with or without AI assistance, which is not the function of this device.

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

Not Applicable. Again, this is a physical laser device, not an algorithm. Its performance is always "standalone" in the sense that it performs its function without an AI element, but it requires a human operator for application.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a medical treatment device like this laser system, the "ground truth" for demonstrating safety and effectiveness would primarily be clinical outcomes data. This includes:
- Observed clinical efficacy: e.g., photographic evidence of lesion clearance, hair reduction, wrinkle improvement.
- Patient feedback: on pain reduction, discomfort.
- Adverse event reporting: to assess safety.
- These outcomes would be assessed by clinicians.

8. The sample size for the training set

Not Applicable. This device does not use a "training set" in the AI/ML sense. Its operational parameters are designed and validated through engineering principles and clinical studies, not by training an algorithm on a dataset.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established in this context.

Summary

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Traditional Pre-market Notification K024093 Additional Information March 13, 2003

JUN 1 9 2003

510(k) Summary

Category:	Comments
Sponsor:	Lumenis, Inc.2400 Condensa StreetSanta Clara, CA 95051
Correspondent:	Andrea L. Ruth, RACSenior Associate II, Regulatory Affairs
Contact Numbers:	408.764.3235
Device Common Name	Laser Powered Surgical Instrument (and Accessories)
Device Proprietary Name	Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems
Device Classification Name	Laser Surgical Instrument for Use in General and plansticSurgery and in Dermatology
Device Classification	21 CFR § 878.4810
Predicate Devices	IPL Quantum Family; VascuLight Family; Lyra™; GentleYAG™
Predicate DeviceManufacturer(s)	Lumenis; Lumenis; LaserScope; Candela
Predicate Device Reference(s)	K020839; K020839; K020021; K022951
Predicate Device ClassificationName(s)	Laser Surgical Instrument for Use in General and Plastic Surgeryand in Dermatology
Predicate DeviceClassification(s)	21 CFR §878.4810

Table 1 - Administrative Information

Date Summary Was Prepared: March 13, 2003.

Description of the Device: Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are comprised of the following main components:

- A light/laser system console (including software and control electronics);
A control and display panel; and *
- One or more attached hand-piece(s), which may have integrated skin cooling components.

Intended Use: The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are intended for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.

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KOJ4093 1/2

Traditional Pre-market Notification K024093 Additional Information March 13, 2003

Predicate Device	This device	Lumenis VascuLightor IPL Quantum Families	Laserscope Lyra™	CandelaGentleYAG
510(k)Reference	Currentsubmission	K020839	K020021	K022951
Intended Use	Photocoagulation,photothermolysisand hemostsisSee indications foruse statement	Photocoagulation,photothermolysis andhemostsis	Treatment of facialwrinkles	Treatment offacial wrinkles
DeviceDescription	IPL andIPL/Nd:YAGcombination	Same	Nd:YAG	Nd:YAG
Output EnergyUsed	Coherent and non-coherent light	Same	Same	Same
EnergyConfiguration	515 - 1200 nm1064nm	Same	1064 nm	1064 nm
Fluence	Up to 150 J/cm²	Same	Up to 250 J/cm²	10 to 70 J/cm²
Pulse	2 to 16 ms(to 48 ms triplepulsed)	Same	10 to 50 ms	3 ms
Pulse Rate	0.33 Hz	Same	1-10 pps	1 Hz
Spot Size	6mm	Same	3mm, 5mm,10mm	12 mm
Beam Delivery	Cooling Hand-piece	Same	Fiber w/coolingaiming beamsapphire crystal	Lens-coupledoptical fiber withhand-piece
Electricity	115/230V	Same	115/230V	230V
SimultaneousDelivery?	No	No	No	No
Single Use?	No	No	No	No
Sterilized?	No	No	No	No
Manufacturer	Lumenis	Lumenis	LaserScope	Candela
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

Table 2 - Comparison to Predicate Devices:

Summary of the Clinical Data: Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective, when indicated in specific applications in the medical specialties of general and plastic surgery, and dermatology.

Conclusion: The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems were shown to be substantially equivalent to the predicate devices cleared in K020839. The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems has identical intended use, as well as functional and design features as the currently marketed predicate devices. The only change is expansion of labeled indications for use, which fall within the scope of the intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2003

Ms. Andrea L. Ruth, RAC Regulatory Affairs Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051

Re: K024093 Trade/Device Name: Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems 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: March 13, 2003 Received: March 21, 2003

Dear Ms. Ruth:

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 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.

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Page 2 - Ms. Andrea L. Ruth, RAC

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2 Indications for Use Statement as Requested by FDA

510(k) Number (if Known): K024093

of Intense Pulsed-Light Device Name: Lumenis Family (IPL) Systems & Combination IPL / Nd:YAG Systems and the Real Time Chiller

Indications For Use:

Intense Pulsed Light Energy / Wavelengths (515 - 1200 nm):

The treatment of tattoos and benign pigmented epidermal and cutaneous lesions * including warts, scars and striae;
- The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-VI through selective targeting of melanin in hair follicles;

1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.

*** Continued on Following Page ***

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

LUMENIS, INC. MODIFIED IPL AND IPLAND: YAG COMBINATION PRODUCT FAMILIES

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510(k) Number (if Known):

K024093

Device Name: Lumenis Family of Intense Pulsed-Light (IPL) Systems & Combination IPL / Nd:YAG Systems and the Real Time Chiller

Indications For Use: *** Continued from Previous Page ***

Nd:YAG Laser Wavelength (1064 nm):

- The coagulation and hemostasis of vascular lesions and soft tissue, including:
  - - Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg;
- The non-ablative treatment of facial wrinkles.

The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:

- Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
Reduce discomfort during and/or associated with light or laser treatment; *
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyperand/or hypopigmentation;
- Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
- Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

OR	Over-The-Counter Use
Miriam C. Provost
Division Sign-Off (Optional Format 1-2-96)

eral, Restorative

LUMENIS, INC.

CONFIDENTIAL.

THE AND IPL/ND:YAG COMBINATION PRODUCT FAMILIES
CONFIDENTIAL
510(k) Number K 624093

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.