The Harmony Lite is intended for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, and aesthetic applications.

Specific indications for use are listed for the following handpieces:

500-600 nm Dye VL Pro Module AFT Hand piece: Treatment of benign cutaneous vascular lesions and use on Fitzpatrick skin types I-V.
540-950 nm VP PRO AFT Hand piece: Treatment of benign pigmented epidermal lesions, cutaneous lesions, benign cutaneous vascular lesions, and use on all skin types (Fitzpatrick I-VI).
570-950 nm SSR Pro Module AFT Hand piece: Treatment of benign pigmented epidermal lesions, face and body vascular and pigmented lesions, cutaneous lesions, benign cutaneous vascular lesions, and use on all skin types (Fitzpatrick I-VI).
590 nm LED Module Handpiece: Provide topical heating to promote increased blood flow for temporary relaxation of muscle and relief of pain, and provide topical heating for the purpose of elevating and/or maintaining tissue temperature.
780-950 nm SHR PRO AFT Module Hand piece: Treatment of pseudofolliculitis barbae (PFB), removal of unwanted hair and to effect stable long-term or permanent hair reduction, and use on all skin types (Fitzpatrick I-VI), including tanned skin.
NIR Large and Small Modules: Temporary relief of minor muscle pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscle back pain.
Thermoelectric Cooler (TEC): 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, discomfort, minimize thermal injury, allow the use of higher light or laser fluences, and reduce potential side effects.

Device Description

The Alma Lasers Harmony Lite Multi-Application Platform is comprised of the following main components:

The main console unit that incorporates the touch-screen control panel, power supply modules, cooling system, switching module, service panel and isolating transformer.
Variety of handpieces, including IPL, LED and NIR modules
Footswitch.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for a medical device called "Alma Harmony Lite." This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a new device's acceptance criteria and related studies in the same way one would find for a novel device.

The "study" described here is primarily a comparative study against previously cleared (predicate) devices to establish substantial equivalence. It's not a study proving novel acceptance criteria for the new device itself, but rather demonstrating that the new device meets the performance and safety profiles of the predicate devices.

Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria is framed within the context of establishing substantial equivalence to predicate devices, rather than an independent validation against pre-defined, standalone acceptance thresholds for a novel device.

Here's the breakdown of the information based on the provided text, interpreted in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission, "acceptance criteria" are implicitly derived from the technical characteristics and indications for use of the predicate devices. The "reported device performance" is the characteristics of the new device that are being demonstrated to be substantially equivalent.

Characteristic	Acceptance Criteria (Predicate Device K072564: Alma Harmony XL Platform)	Reported Device Performance (Alma Harmony Lite)	Substantial Equivalence Demonstrated?
Dye VL Pro IPL Handpiece (New device)
Wavelength (nm)	VL515 Handpiece: 515nm-950nm	500-600nm	Yes (within range / comparable intended use)
Intended Use	Aesthetic/cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in general/plastic surgery and dermatology	Same	Yes
Indications for Use	Benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, erythema of rosacea, angiomas, spider angiomas, poikiloderma of Civatte, leg veins and venous malformations). For Use on skin types (I-V). Also included moderate inflammatory acne, tattoos, benign pigmented epidermal and cutaneous lesions	Benign cutaneous vascular lesions (port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations). For Use on skin types (I-V).	Yes (Subset of predicate indications, implies equivalence where applicable)
Pulse Width (msec)	10, 12, 15	10, 12, 15	Yes
Pulse Repetition Rate (Hz)	2/3	2/3	Yes
Energy Density (Fluence) (J/cm²)	10-30	10-30	Yes
Spot Size (mm)	3 cm²	3 cm²	Yes
VP PRO AFT Handpiece (New device)
Wavelength (nm)	540-950nm (Previously Cleared K072564 – Alma IPL handpiece VL/PL, VP and SSR)	540-950nm	Yes
Intended Use	Aesthetic/cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in general/plastic surgery and dermatology	Same	Yes
Indications for Use	Treatment of moderate inflammatory acne vulgaris; benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides, lentigines, nevi, cafe-au-lait macules); cutaneous lesions (warts, scars, striae); benign cutaneous vascular lesions; removal of unwanted hair. Use on all skin types (I-VI).	Benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides, lentigines, nevi, melasma, cafe-au-lait macules); benign cutaneous vascular lesions (port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations). Use on all skin types (Fitzpatrick I-VI).	Yes (Comparable intended use and indications)
Energy Density (Fluence) (J/cm2)	10-30	10-30	Yes
Pulse Repetition Rate (Hz)	2/3	2/3	Yes
Pulse Width (msec)	10, 12, 15	10, 12, 15	Yes
Spot Size (mm)	3 cm2	3 cm2	Yes
SSR Pro Module AFT Handpiece (New device)
Wavelength (nm)	570-950 (K072564 - Alma SR IPL handpiece)	570-950	Yes
Intended Use	Aesthetic/cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in general/plastic surgery and dermatology	Same	Yes
Indications for Use	Moderate inflammatory acne vulgaris; benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides); face and body vascular and pigmented lesions; cutaneous lesions (scars, striae); benign cutaneous vascular lesions; removal of unwanted hair. Use on all skin types (Fitzpatrick I-VI).	Benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma and ephelides); face and body vascular and pigmented lesions; cutaneous lesions (scars and striae); benign cutaneous vascular lesions; melasma. Use on all skin types (Fitzpatrick I-VI).	Yes (Comparable intended use and indications)
Energy Density (Fluence) (J/cm²)	10-25 J/cm²	10-25 J/cm²	Yes
Pulse Repetition Rate (Hz)	2/3	2/3	Yes
Pulse Width (msec)	10,12,15 msec	10,12,15 msec	Yes
Spot size (mm)	3, 6 cm²	3 cm²	Yes (Smaller spot size is typically considered safer/similar)
SHR PRO AFT Module Handpiece (New device)
Wavelength (nm)	780-950 (K072564 - Alma SHR IPL)	780-950	Yes
Intended Use	Aesthetic/cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in general/plastic surgery and dermatology	Same	Yes
Indications for Use	Treatment of pseudofolliculitis barbae (PFB); removal of unwanted hair and to effect stable long-term or permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin.	Removal of unwanted hair; effect stable or permanent hair reduction; treatment of pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-VI), including tanned skin.	Yes (Comparable intended use and indications)
Pulse Width (msec)	30,40,50 msec	30,40,50 msec	Yes
Pulse Repetition Rate (Hz)	4	4	Yes
Energy Density (Fluence)	1-5 J/cm2 for SHR; 5-25J/cm2 for HR	1-5 J/cm2 for SHR; 5-25J/cm2 for HR	Yes
Spot Size (mm)	3 cm2	3 cm2	Yes
590 nm LED Module Handpiece (New device)
Intended Use	Intended for use in dermatologic procedures	Same	Yes
Indications for Use	Provide topical heating to promote increased blood flow for temporary relaxation of muscle and relief of pain; provide topical heating for the purpose of elevating and/or maintaining tissue temperature.	Same	Yes
Wavelength (nm)	590 (amber)	590 (amber)	Yes
Output power (mW)	1,800	1,800	Yes
Treatment Area	0.9 cm2 (0.14 sq.in.)	0.9 cm2 (0.14 sq.in.)	Yes
Mode	Pulsed/Continuous Wave (CW)	Pulsed/Continuous Wave (CW)	Yes
NIR Large Module (New device)
Product Code & Regulation No.	ILY, 21CFR 890.5500	ILY, 21CFR 890.5500	Yes
Wavelength (nm)	1300	1300	Yes
Lamp Type	Quartz Tube	Quartz Tube	Yes
Intended Use	Emit energy in the infrared spectrum to provide topical heating for elevating tissue temperature	Same	Yes
Indications for Use	Temporary relief of minor muscle pain and joint pain and stiffness, minor joint pain associated with arthritis, temporary increase in local circulation, relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.	Same	Yes
Power Control	Time control	Time control	Yes
Mode	Pulsed	Pulsed	Yes
Fluence (J/cm2)	0.55-5.5	0.55-5.5	Yes
Pulse Width (sec)	1-5	1-5	Yes
Spot Size (mm*mm or cm2)	18	18	Yes
Cooling	Contact cooling, Thermo-electric (TEC)	Contact cooling, Thermo-electric (TEC)	Yes
Treatment Mode	In-motion	In-motion	Yes
Exposure Indicator	Audible & visual indicator	Audible & visual indicator	Yes
NIR Small Module (New device)	(Comparable to NIR Large Module's predicate)
Product Code & Regulation No.	ILY, 21CFR 890.5500	ILY, 21CFR 890.5500	Yes
Wavelength (nm)	1300	1300	Yes
Lamp Type	Quartz tube	Quartz tube	Yes
Intended Use	Emit energy in the infrared spectrum to provide topical heating for elevating tissue temperature	Same	Yes
Indications for Use	Same as NIR Large Module	Same as NIR Large Module	Yes
Power Control	Time control	Time control	Yes
Mode	Pulsed	Pulsed	Yes
Fluence (J/cm²)	5.5 (Note: predicate lists single value, new device lists range, but range includes 5.5)	0.55-5.5	Yes
Pulse Width (sec)	1 - 5	1-5	Yes
Spot Size (mm*mm or cm²)	6.4	6.4	Yes
Cooling	Contact cooling, Thermo-electric (TEC)	Contact cooling, Thermo-electric (TEC)	Yes
Treatment Mode	In-motion	In-motion	Yes
Exposure Indicator	Audible & visual indicator	Audible & visual indicator	Yes

Note on Acceptance Criteria: For a 510(k), the primary "acceptance criterion" is proving substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and safety/effectiveness. The table above reflects this comparison, rather than an independent performance metric set for a novel device.

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

The document explicitly states:

"Collateral animal data was presented on a pig study performed at the University of California for the Dye VL Pro handpiece."
This study compared results from IPL experiments to acquired pulsed dye laser (PDL) data from a previous study.
It does not specify the sample size (number of pigs or specific test cases) used for this study.
Data Provenance: The study was performed at the University of California. The nature of the study (comparing IPL results to previous PDL data) suggests it's a prospective animal study for the IPL component, with historical (presumably retrospective) data used for comparison.

For other handpieces/modules: The submission primarily relies on comparing the technical characteristics and indications for use of the new device (Alma Harmony Lite) to those of the predicate devices (K072564 Alma Harmony XL Platform, K140009 The Modified Alma Lasers Soprano XL Family of Multi-Application and Multi-Technology Platforms). This implies that efficacy and safety for these other components are covered by the established profile of the predicate devices, rather than new human or animal test data being presented for every component.

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

The document does not mention human experts establishing ground truth for the animal study or any clinical test set. The animal study compares physiological effects (vascular shutdown) to previously acquired data. For the 510(k), equivalence is established by comparing technical specifications and intended uses, which does not typically involve human expert adjudication of a test set in the same way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a clinical or expert-adjudicated test set in the conventional sense for the Alma Harmony Lite's submission. The pig study's "ground truth" was likely derived from objective physiological measurements and comparison to historical 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. The Alma Harmony Lite is a laser and light-based aesthetic/surgical platform, not an AI-powered diagnostic imaging device that would involve human "readers" or an "AI assistance" component in an MRMC study.

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

Not applicable. This device is not an algorithm, but a physical medical device (laser/light platform).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the animal study on the Dye VL Pro handpiece:
"Ground truth" was established by physiological observations (persistent vascular shutdown) in pigs and comparison to previously acquired pulsed dye laser (PDL) data, which would have its own established ground truth for efficacy. The methodology ("Monte Carlo simulations to investigate the relationship between absorbed energy, wavelength, and penetration depth") indicates a biophysical basis for evaluating the treatment effect.

For the substantial equivalence of the other modules, the "ground truth" is the established safety and efficacy profile of the predicate devices (K072564 and K140009), based on their previously approved indications and technical characteristics.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device (laser/light platform), not an AI algorithm that requires a "training set."

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three overlapping profiles facing right, resembling a family or group of people.

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

March 13, 2015

Alma Lasers Incorporated % Ms. Kathy Maynor USA Regulatory 26 Rebecca Court Homosassa, Florida 34446

Re: K141237 Trade/Device Name: Alma Harmony Lite 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, ILY Dated: February 4, 2015 Received: February 6, 2015

Dear Ms. Maynor:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141237

Device Name Alma Harmony Lite

Indications for Use (Describe)

Indications for Use :

500-600 nm Dye VL Pro Module AFT Hand piece

The Advanced Fluorescence Technology (AFT) Dye VL Pro Module handpiece (with and without contact-cooling) is indicated for:

• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and legtelangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.

• For use on Fitzpatrick skin types I-V.

540-950 nm VP PRO AFT Hand piece

The Advanced Fluorescence Technology (AFT) VP ProModule handpieces (with and without contact-cooling) are indicated for:

·The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles),lentigines, nevi, melasma, and cafe-au-lait macules.

· The treatment of cutaneous lesions including warts, scars and striae.

· Use on all skin types (Fitzpatrick I-VI).

570-950 nm SSR Pro Module AFT Hand piece

The Advanced Fluorescence Technology (AFT) 570-950 nm SSR Module handpiece (with and without contact-cooling) is indicated for:

·The treatment of benign pigmented epidermal lesions, including dyschromia , hyperpigmentation, melasma and ephelides (freckles).

· The treatment of face and body vascular and pigmented lesions.

· The treatment of cutaneous lesions, including scars and striae.

· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias,rosacea, melasma, angiomas, poikiloderma of Civatte, leg veins and venous malformations.

•Use on all skin types (Fitzpatrick I-VI).

590 nm LED Module Handpiece

The 590 nm LED module handpiece is indicated to:

· Provide topical heating to promote increased blood flow for temporary relaxation of muscle and relief of pain .

· Provide topical heating for the purpose of elevating and/or maintaining tissue temperature.

780-950 nm SHR PRO AFT Module Hand piece

The Advanced Fluorescence Technology (AFT) 780-950 nm SHR PRO (with and without contactcooling) is indicated for: •The treatment of pseudofolliculitis barbae (PFB).

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•The removal of unwanted hair and to effect stable long-term or permanent hair reduction in hairregrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12months after the completion of the treatment regime.

NIR Large and Small Modules :

The NIR Modules are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles: may also help muscle spasms, minor sprains and strains, and minor muscle back pain.

Thermoelectric Cooler (TEC)

The thermoelectric cooler, integrated into the light and laser handpieces, 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;

· 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 orlaser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/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 orpigmented lesions); and

· Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 8 - 510(k) Summary or 510(k) Statement

I. General Information

Submitter:	Alma Lasers Inc.485 Half Day Rd. Suite 100Buffalo Grove, IL 60089
Contact Person:	Avi FarbsteinGeneral Manager, EVPAlma Lasers Inc.
	Kathy MaynorUSA RegulatoryAlma Lasers Inc.
Summary Preparation Date:	March 12, 2015

II. Names

Device Names:	Harmony Lite Multi-Application Platform
Primary Classification Names:	Surgical Powered Light Instrument, Ultraviolet DermatologicalLight, and LED Phototherapy device

III. Predicate Devices

K072564 Alma Harmony XL Plarform
K140009 The Modified Alma Lasers Soprano XL Family of Multi-Application and Multi-Technology Platforms

IV. Product Description

The Alma Lasers Harmony Lite Multi-Application Platform is comprised of the following main components:

. The main console unit that incorporates the touch-screen control panel, power supply modules, cooling system, switching module, service panel and isolating transformer.
Variety of handpieces, including IPL, LED and NIR modules ●
Footswitch.

V. Indications for Use

The Alma Lasers Harmony Lite Multi-Application Platform is intended for use in dermatologic and general surgical procedures.

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The Indications for Use of the Harmony Lite Multi-Application Platform are provided in the tables below.

	Dye VL Pro IPL Handpiece – this submission	K072564 - AlmaVL515 IPL handpiece

		Primary Predicate
Characteristic
Wavelength(nm)	500-600nm	VL515 Handpiece(515nm-950nm)
Intended Use	Intended for use in aesthetic and cosmeticapplications requiring selective photothermolysis(photocoagulation or coagulation) and hemostasisof soft tissue in the medical specialties of generaland plastic surgery, and dermatology	Intended for use in aesthetic and cosmeticapplications requiring selective photothermolysis(photocoagulation or coagulation) and hemostasisof soft tissue in the medical specialties of generaland plastic surgery, and dermatology
Indications forUse	Indicated for the treatment of:• Benign cutaneous vascular lesions,including port wine stains, hemangiomas,facial, truncal and leg telangiectasias,rosacea, erythema of rosacea,, angiomasand spider angiomas, poikiloderma ofCivatte, leg veins and venousmalformations• For Use on skin types (I-V)	Indicated for the treatment of:• Moderate inflammatory acne (acnevulgaris)• Tattoos and benign pigmented epidermaland cutaneous lesions including warts,scars ,striae; dyschromia,hyperpigmentation, melasma, epithelides(freckles), lentigines, nevi, and café-au-laitmacules• Benign cutaneous vascular lesions,including port wine stains, hemangiomas,facial, truncal and leg telangiectasias,rosacea, erythema of rosacea, angiomasand spider angiomas, poikiloderma ofCivatte, leg veins and venousmalformations• For use on skin types (I-V)
Pulse Width	10,12,15	10, 12, 15
(msec)
PulseRepetitionRate (Hz)	2/3	2/3
EnergyDensity(Fluence)(J/cm²)	10-30	10-30
Spot Size(mm)	3 cm²	3 cm²
	VP PRO – this submission	Previously Cleared K072564 – Alma IPLhandpiece VL/PL, VP and SSR
		Primary Predicate
Characteristic
Wavelength	540-950nm	540-950nm
Intended Use	Intended for use in aesthetic and cosmeticapplications requiring selectivephotothermolysis (photocoagulation orcoagulation) and hemostasis of soft tissuein the medical specialties of general andplastic surgery, and dermatology	Intended for use in aesthetic and cosmeticapplications requiring selectivephotothermolysis (photocoagulation orcoagulation) and hemostasis of soft tissue inthe medical specialties of general and plasticsurgery, and dermatology
Indications for Use	Indicated for the treatment of:The treatment of benign pigmentedepidermal lesions includingdyschromia, hyperpigmentation,melasma, and ephelides (freckles),lentigines, nevi, melasma, andcafe-au-lait macules. The treatment of benign cutaneousvascular lesions including portwine stains, hemangiomas, facial,truncal and leg telangiectasias,rosacea, erythema of rosacea,angiomas and spider angiomas,poikiloderma of Civatte, leg veinsand venous malformations. Use on all skin types (Fitzpatrick I-VI).	The treatment of moderateinflammatory acne vulgaris. The treatment of benign pigmentedepidermal lesions including dyschromiahyperpigmentation, melasma, andephelides (freckles), lentigines, nevi,melasma, and cafe-au-lait macules. The treatment of cutaneous lesionsincluding warts, scars and striae. The treatment of benign cutaneousvascular lesions including port winestains, hemangiomas, facial, truncal andleg telangiectasias, rosacea, erythema ofrosacea, angiomas and spider angiomas,poikiloderma of Civatte, leg veins andvenous malformations. The removal of unwanted hair to effectstable long-term or permanent hairreduction. Use on all skin types (Fitzpatrick I-VI).
Energy Density(Fluence) (J/cm2)	10-30	10-30
Pulse RepetitionRate (Hz)	2/3	2/3
Pulse Width(msec)	10, 12, 15	10, 12, 15
Spot size	3 cm2	3 cm2
	This submission – SSR IPL handpiece	K072564 - Alma
		SR IPL handpiece
		Primary Predicate
Characteristic
Wavelength(nm)	570-950	570-950
Intended Use	Intended for use in aesthetic and cosmeticapplications requiring selectivephotothermolysis (photocoagulation orcoagulation) and hemostasis of soft tissue inthe medical specialties of general andplastic surgery, and dermatology	Intended for use in aesthetic and cosmeticapplications requiring selectivephotothermolysis (photocoagulation orcoagulation) and hemostasis of soft tissue inthe medical specialties of general and plasticsurgery, and dermatology
Indications forUse	The Advanced FluorescenceTechnology (AFT) 570-950 nm SSRModule handpiece (with and withoutcontact-cooling) is indicated for:● The treatment of benign pigmentedepidermal lesions, includingdyschromia, hyperpigmentation,melasma and ephelides (freckles).● The treatment of face and bodyvascular and pigmented lesions.● The treatment of cutaneous lesions,including scars and striae.● The treatment of benign cutaneousvascular lesions, including portwine stains, hemangiomas, facial,truncal and leg telangiectasias,rosacea, melasma, angiomas andspider angiomas, poikiloderma ofCivatte, leg veins and venousmalformations.● Use on all skin types (Fitzpatrick I-VI).	The Advanced Fluorescence Technology(AFT) 570-950 nm SR Module handpiece(with and without contact-cooling) isindicated for:● The treatment of moderateinflammatory acne vulgaris.● The treatment of benign pigmentedepidermal lesions, includingdyschromia, hyperpigmentation,melasma and ephelides (freckles).● The treatment of face and bodyvascular and pigmented lesions.● The treatment of cutaneous lesions,including scars and striae.● The treatment of benign cutaneousvascular lesions, including port winestains, hemangiomas, facial, truncaland leg telangiectasias, rosacea,melasma, angiomas and spiderangiomas, poikiloderma of Civatte,leg veins and venous malformations.● The removal of unwanted hair toeffect stable long-term or permanenthair reduction.● Use on all skin types (Fitzpatrick I-VI).
Energy Density(Fluence)(J/cm²)	10-25 J/cm²	10-25 J/cm²
PulseRepetition Rate(Hz)	2/3	2/3
Pulse Width(msec)	10,12,15 msec	10, 12, 15 msec
Spot size (mm)	3 cm²	3, 6 cm²
	This submissionSHR IPL handpiece	Previously Cleared K072564 - Alma SHR IPL
		Primary Predicate
Characteristic
Wavelength(nm)	780-950	780-950
Intended Use	Intended for use in 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	Intended for use in 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
Indications for Use	The Advanced Fluorescence Technology (AFT) 780-950 rnm SHR Module handpiece (with and without contact-cooling) is indicated for:• Removal of unwanted hairEffect stable or permanent hair reduction.Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime• The treatment of pseudofolliculitis barbae (PFB).• Use on all skin types (Fitzpatrick I-VI), including tanned skin	The Advanced Fluorescence Technology (AFT) 780-950 rnm SHR handpieces (with and without contact-cooling) is indicated for:• The treatment of pseudofolliculitis barbae (PFB).• The removal of unwanted hair and to effect stable long-term or permanent hair reduction.• Use on all skin types (Fitzpatrick I-VI), including tanned skin.
Pulse Width(msec)	30,40,50 msec	30,40,50 msec
Pulse RepetitionRate (Hz)	4	4
Energy Density(Fluence)	1-5 J/cm2 for SHR5-25J/cm2 for HR	1-5 J/cm2 for SHR5-25J/cm2 for HR
Spot Size (mm)	3 cm2	3 cm2

VI. Summary of Technical Characteristics

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	LED Handpiece - Nomodifications - this	Previously Cleared K072564Alma Lasers LED Handpiece
	submission	Primary Predicate
Characteristic
Intended Use	Intended for use in dermatologicprocedures	Intended for use in dermatologicprocedures
Indications for Use	The 590 nm LED modulehandpiece is indicated to: ·	The 590 nm LED modulehandpiece is indicated to: ·
	● Provide topical heating topromote increased bloodflow for temporary relaxationof muscle and relief of pain.	· Provide topical heating topromote increased blood flowfor temporary relaxation ofmuscle and relief of pain.
	· Provide topical heating forthe purpose of elevatingand/or maintaining tissuetemperature.	Provide topical heating for●the purpose of elevatingand/or maintaining tissuetemperature.
Wavelength (nm)	590 (amber)	590 (amber)
Output power(mW)	1.800	1,800
Treatment Area	0.9 cm2 (0.14 sq.in.)	0.9 cm2 (0.14 sq.in.)
Mode	Pulsed/Continuous Wave(CW)	Pulsed/Continuous Wave(CW)

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	This submissionAlma Lasers NIR Large Module	K140009Alma Lasers NIR Module
		Primary Predicate
Parameter
Product Code &Regulation No.	ILY21CFR 890.5500	ILY21 CFR 890.5500
Wavelength [nm]	1300	1300
Lamp Type	Quartz Tube	Quartz tube
Intended Use	Intended to emit energy in the infraredspectrum to provide topical heating for thepurpose of elevating the tissuetemperature	Intended to emit energy in the infraredspectrum to provide topical heating forthe purpose of elevating the tissuetemperature
Indications for Use	For the temporary relief of minor musclepain and joint pain and stiffness, thetemporary relief of minor joint painassociated with arthritis, the temporaryincrease in local circulation whereapplied, and the relaxation of muscles;may also help muscle spasms, minorsprains and strains, and minor muscularback pain.	For the temporary relief of minor musclepain and joint pain and stiffness, thetemporary relief of minor joint painassociated with arthritis, the temporaryincrease in local circulation whereapplied, and the relaxation of muscles;may also help muscle spasms, minorsprains and strains, and minor muscularback pain.
Power Control	Time control	Time control
Mode	Pulsed	Pulsed
Fluence [J/cm2]	0.55-5.5	0.55-5.5
Pulse Width [sec]	1-5	1 - 5
Spot Size [mm*mm] or cm2]	18	18
Cooling	Contact coolingThermo-electric (TEC)	Contact coolingThermo-electric (TEC)
Treatment Mode	In-motion	In-motion
ExposureIndicator	Audible & visual indicator	Audible & visual indicator
How Supplied	Non-sterile, cleanable	Non-sterile, cleanable
ModuleDimensions	1908056mm (LWH)	1908056mm (LWH)

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	This submission	K140009
	Alma Lasers NIR Small Module	Alma Lasers NIR Module
		Primary Predicate

Parameter
Product Code &	ILY	ILY
Regulation No.	21 CFR 890.5500	21 CFR 890.5500
Wavelength [nm]	1300	1300
Lamp Type	Quartz tube	Quartz tube
Intended Use	Intended to emit energy in the infraredspectrum to provide topical heating forthe purpose of elevating the tissuetemperature	Intended to emit energy in the infraredspectrum to provide topical heating forthe purpose of elevating the tissuetemperature
Indications forUse	For the temporary relief of minor musclepain and joint pain and stiffness, thetemporary relief of minor joint painassociated with arthritis, the temporaryincrease in local circulation whereapplied, and the relaxation of muscles;may also help muscle spasms, minorsprains and strains, and minor muscularback pain.	For the temporary relief of minor musclepain and joint pain and stiffness, thetemporary relief of minor joint painassociated with arthritis, the temporaryincrease in local circulation where applied,and the relaxation of muscles; may alsohelp muscle spasms, minor sprains andstrains, and minor muscular back pain.
Power Control	Time control	Time control
Mode	Pulsed	Pulsed
Fluence [J/cm²]	.55-5.5	5.5
Pulse Width [sec]	1-5	1 - 5
Spot Size[mm*mm] or[cm²]	6.4	6.4
Cooling	Contact coolingThermo-electric (TEC)	Contact coolingThermo-electric (TEC)
Treatment Mode	In-motion	In-motion
ExposureIndicator	Audible & visual indicator	Audible & visual indicator
How Supplied	Non-sterile, cleanable	Non-sterile, cleanable

VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Harmony Lite Multi-Application Platform is substantially equivalent to the predicate devices. Additional safety testing was performed as discussed in section 18 of the submission.

The Alma Harmony Lite was tested by a certified laboratory in accordance with:

IEC 60601-1:2005 + Corr.1 (2006) + Corr. 2 (2007) Medical Electrical Equipment: Part 1 General Requirements for Basic Safety and Essential Performance

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IEC60601-1-2: 2007 Medical electrical equipment: Part 1-2; Collateral Standard: Electromagnetic compatibility - Requirements and tests

IEC 60601-2-57: 2011 1st edition" Medical electrical equipment: Part 2: Particular requirements for the basis safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

The software was documented, verified and validated (test reports in submission) in accordance with IEC 62304:2006 - Medical Device Software: Software Life Cycle Processes and ISO 14971:2012 - Medical Devices: Application of Risk Management to Medical Devices.

VIII. Animal Data

Collateral animal data was presented on a pig study performed at the University of California for the Dye VL Pro handpiece. We compared the results from our IPL experiments to acquired pulsed dye laser (PDL) data from a previous study and determined that IPL treatments can also produce persistent vascular shutdown. We ran Monte Carlo simulations to investigate the relationship between absorbed energy, wavelength, and penetration depth. The data collectively demonstrate the potential to achieve removal of vascular lesions using the IPL.

IX. Conclusion

The Alma Lasers Harmony Lite Multi-Application Platform was found to be substantially equivalent to the predicate devices.

The Alma Lasers Harmony Lite Multi-Application Platform shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.

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.