The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are intended to be used with the Harmony XL™ Multi-Application Platform for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), general neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, podiatry, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.

Indications for Use:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

Matrixectomy
Periungual and subungual warts
Plantar warts
Radical nail excision
Neuromas

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (Long Pulsed and Q-Switched) are intended for use with the Harmony XL™ Multi-Application Platform for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) are indicated for treatment and clearance of:

Benign vascular lesions such as, but not limited to treatment of: Port wine stains, Hemangiomas, Warts, Superficial and deep telangiectasias (venulectasias), Reticular veins (0.1-4.0 mm dia.) of the leg, Rosacea, Venus lake, Leg veins, Spider veins, Poikiloderma of Civatte, Angiomas
Benign cutaneous lesions, such as, but not limited to: Warts, Scars, Striae, Psoriasis
Benign pigmented lesions such as, but not limited to: Lentigos (age spots), Solar lentigos (sun spots), Cafe-au-lait macules, Seborrheic keratoses, Nevi and nevus of Ota, Chloasma, Verrucae, Skin tags, Keratoses, The removal of black, blue or green tattoos (significant reduction in the intensity of black and for blue/black tattoos), Plaques
Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles, Perioral wrinkles
Laser skin resurfacing procedures for the treatment of: Acne scars, Wrinkles
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The 1064 nm Nd: YAG lasers (Long Pulsed only, with and without contact-cooling) is indicated for:

Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
Removal or lightening of unwanted hair (with and without adjuvant preparation)
Treatment of pseudofolliculitis barbae (PFB)

Device Description

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules for use in podiatry and for the temporary increase in clear nail in patients with onychomycosis is a laser handpiece that contains the optical bench that emits the high power Nd: YAG laser beam. The Modified Alma Lasers Harmony 1064nm (Nd: YAG) Modules are designed to be used with the Harmony XL™ Muli-Application Platform [Accent, Accent XL, Accent Beauty] for the delivery of long-pulse or O-switched laser energy. The patient contact portion of the Modified Alma Lasers Harmony 1064nm (Nd. YAG) Modules is a removable, cleanable, sterilizable stand-off tip.

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are comprised of the following main components:

Handpiece Housing
Incorporates the optical head (laser)
Handpiece trigger.
Standoff-Tip (cleanable/ sterilizable)
Laser emission indicator illuminates prior to- and during laser energy emission
Umbilical cable houses the wiring to the Harmony XLTM Muli-Application Platform
Module (handpiece) connector - connects the handpiece umbilical cable to its port on the Harmony XLTM Muli-Application Platform.

AI/ML Overview

This document is a 510(k) Premarket Notification for the "Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules". This type of submission to the FDA focuses on establishing substantial equivalence to existing legally marketed devices (predicates), rather than proving safety and efficacy through clinical trial data with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical performance evaluation against predefined endpoints. Instead, it asserts substantial equivalence based on technological characteristics and intended use.

Here's a breakdown of why the requested information isn't present in this type of submission and what the document does provide:

A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria or specific device performance metrics from a clinical study. The tables in the document (pages 3-4) compare the technological characteristics of the subject device (Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules) to those of predicate devices, not clinical performance. The "acceptance criteria" here is implicitly reaching substantial equivalence in technological characteristics and intended use to the predicates.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided. No "test set" in a clinical performance sense is referenced. The submission relies on a comparison of device specifications to predicates.
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): Not applicable/Not provided. There is no clinical "test set" requiring ground truth established by experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. No clinical "test set" requiring adjudication is detailed.
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 provided. This device is a laser system, not an AI diagnostic tool. MRMC studies are not relevant to this type of submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is a hardware laser device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. There is no clinical ground truth established or used for performance evaluation in this 510(k). The clinical experience of the predicate devices is implied validation for the similar new device.
The sample size for the training set: Not applicable/Not provided. This is a hardware device; machine learning "training sets" are not part of its development or submission.
How the ground truth for the training set was established: Not applicable/Not provided. As above, no training set for machine learning is involved.

Summary of what the document does provide regarding "acceptance criteria" for substantial equivalence:

The "acceptance criteria" in a 510(k) context are that the new device has the same intended use and technological characteristics as a predicate device, or that any differences in technological characteristics do not raise new questions of safety and effectiveness.

Intended Use & Indications for Use: Pages 1, 2, 8, 9, 10 clearly list the intended use and extensive indications for use in various medical specialties, including podiatry for temporary increase in clear nail in onychomycosis, benign vascular lesions, benign cutaneous lesions, benign pigmented lesions, non-ablative treatment of facial wrinkles, laser skin resurfacing, reduction of red pigmentation in scars, and hair removal. This is compared to the indications for use of the predicate devices implicitly.
Technological Characteristics Comparison (Tables on pages 3-4): The document provides detailed tables comparing the key technical specifications of the Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (Long Pulsed and Q-Switched) to those of the predicate devices. These characteristics include:
- Treatment wavelength (1064 nm Nd:YAG)
- Spot Size
- Pulse Energy
- Pulse Duration
- Laser Power
- Energy Density
- Repetition Rate
- Patient Contact Materials
- How provided (Reusable, non-sterile, cleanable, sterilizable tip)
- Electrical Requirements
- System Dimensions and Weight
Rationale for Substantial Equivalence (Page 5): The submission explicitly states: "The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (used with the Harmony XL™ Muli-Application Platform) share the same indications for use, device operation, overall technical and functional capabilities, and therefore are substantially equivalent to the predicate devices."

In conclusion, this 510(k) submission does not present a clinical study with acceptance criteria and performance data as requested in the prompt. Instead, it demonstrates substantial equivalence to predicate devices based on a comparison of intended uses and technological characteristics.

Summary

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:・

Section 5-510(k) Summary .

l. General Information

Submitter:

Alma Lasers, Inc. 485 Half Day Rd. Suite No. 100 Buffalo Grove, IL 68900, USA

Contact Person:

Tatiana Epstein VP Regulatory Affairs 224-377-2011

Summary Preparation Date:

December 21, 2011 ·

II. Names

Device Name(s):

Modified Alma Lasers Harmony 1064nm (Nd: Y AG) Modules

Classification Information:

Surgical Powered Laser Instrument (and accessories) Classification Name(s): ●
Product Code(s): ●

Regulation(s):

GEX US Title 21 Part 878.4810

Predicate Devices III.

Cutera GenesisPlus Laser System, manufactured by Cutera, Inc. (K103626) .
PinPointe™ FootLaser™ manufactured by PinPointe USA, Inc. (K093547) . .
PinPointe™. FootLaser™ (Model 6W, 30W, 100W), manufactured by Incisive, Inc. ● (K093545)
Q-Clear™ Nd: Y AG Laser, manufactured by Light Age, Inc. (K 1 10370) ●
Alma Lasers Harmony XL™ Muli-Application Platform, manufactured by Alma ● Lasers (K072564)

IV. Product Description

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules for use in podiatry and for the temporary increase in clear nail in patients with onychomycosis is a laser handpiece that contains the ontical bench that emits the high power Nd: YAG laser beam. The Modified Alma Lasers Harmony 1064nm (Nd: YAG) Modules are designed to be used with the Harmony XL™ Muli-Application Platform [Accent, Accent XL, Accent Beauty] for the delivery of long-pulse or O-switched laser energy. The patient contact portion of the Modified Alma Lasers Harmony 1064nm (Nd. YAG) Modules is a removable, cleanable, sterilizable stand-off tip.

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are comprised of the following main components:

Handpiece Housing ●
- Incorporates the optical head (laser) A
- Handpiece trigger. A

Premarket Notification, 510(k) Submission for: Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules for Podiatry and the Temporary Increase in Clear Nail Section 5: 510(k) Summary - Page 5-1

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

Standoff-Tip (cleanable/ sterilizable) A
Laser emission indicator illuminates prior to- and during laser energy emission
Umbilical cable houses the wiring to the Harmony XLTM Muli-Application . Platform
. Module (handpiece) connector - connects the handpiece umbilical cable to its port on the Harmony XLTM Muli-Application Platform.

V. Intended Use & Indications for Use

Intended Use

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are intended to be used with the Harmony XL™ Muli-Application Platform for use in aestheric, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), general neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, podiatry, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.

Indications for Use

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Module handpieces (Long Pulsed and Q-Switched without contact-cooling) used with the Harmony XLTM Muli-Application Platform are indicated for use in:

Podiatry

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

. Matrixectomy
Periungual and subungual warts .
Plantar warts ●
Radical nail excision ●
. Neuromas

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (Long Pulsed and Q-Switched) are intended for use with the Harmony XLTM Multi-Application Platform for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) are indicated for treatment and clearance of.

Benign vascular lesions such as, but not limited to treatment of: .
- Port wine stains
- Hemangiomas
- Warts A
- Superficial and deep telangiectasias (venulectasias) A
- Reticular veins (0.1-4.0 mm dia.) of the leg A
- A Rosacea
- 八 Venus lake
- A Leg veins

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A Spider veins
ﻪ Poikiloderma of Civatte
A Angiomas
Benign cutaneous lesions, such as, but not limited to: ●
- Warts
- A Scars
- A Striae
- A Psoriasis
Benign pigmented lesions such as, but not limited to: .
- Lentigos (age spots) A
- Solar lentigos (sun spots) A
- A Cafe-au-lait macules
- Seborrheic keratoses A
- A Nevi and nevus of Ota-
- A Chloasma
- A Verrucae
- Skin tags
- Keratoses
- The removal of black, blue or green tattoos (significant reduction in the A intensity of black and for blue/black tattoos).
- A Plaques
Pigmented lesions to reduce lesion size, for patients with lesions that would ● potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The non-ablative treatment of facial wrinkles, such as, but not limited to: .
- Periocular wrinkles A
- » Perioral wrinkles
Laser skin resurfacing procedures for the treatment of: ●
- Acne scars
- Wrinkles
Reduction of red pigmentation in hypertrophic and keloid scars where . vascularity is an integral part of the scar.
·Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. .

The 1064 nm Nd: YAG lasers (Long Pulsed only, with and without contact-cooling) is indicated for:

Removal of unwanted hair, for stable long-term, or permanent, hair reduction . through selective targeting of melanin in hair follicles.
Removal or lightening of unwanted hair (with and without adjuvant ● preparation)
Treatment of pseudofolliculitis barbae (PFB) .

Summary of Technological Characteristics VI.

The technological characteristics of the Modified Alma Lasers Harmony 1064nm (Nd: Y AG) Modules are substantially equivalent to those of the predicate devices.

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	Long Pulsed Module
	K1JModified Alma LasersHarmony 1064nm (Nd:YAG)Module (Long Pulsed)Alma Lasers, Inc.	K103626CuteraGenesisPlusLaser SystemCutera, Inc.	K093547 &K093545PinPointeTMFootLaserTM(Model 6W, 30W,100W)PinPointe USA &Incisive, Inc.	K072564Alma Lasers Harmony XLTM Muli-Application PlatformAlma Lasers, Ltd.
CharacteristicProduct CodeRegulation	General & Plastic SurgeryGEX, 21 CFR 878.4810		General & Plastic SurgeryGEX, 21 CFR 878.4810		General & Plastic SurgeryGEX, 21 CFR 878.4810
Treatment λ	1064 nm (Nd:YAG)		1064 nm(Nd:YAG)	1064 nm(Nd:YAG)	1064 nm (Nd:YAG)
Spot Size	1 mm dia.	1.5 mm dia.	1 mm dia.	1-1.5 mm dia.	2 mm dia.	6 mm dia.	10 mm dia.
Pulse Energy	20-3500 mJ	20-3500 mJ	20-3500 mJ	20-3500 mJ	400-1,200 mJ
Pulse Duration	0.1 - 3.0 ms	0.1 - 3.0 ms	0.1 - 3.0 ms	0.1 - 3.0 ms	8-15 ms	40-60 ms	15 ms
Laser Power	≤ 100 W		≤ 100 W	≤ 100 W	0.4 - 1.2W	0.4 - 1.2W	0.4 - 1.2W
Energy Density	25.5 J/cm²	25.5 J/cm²	25.5 J/cm²(1 mm dia.spot)	25.5 J/cm² (1 mmdia. spot)	30-450J/cm²	30-150J/cm²	30-150 J/cm²
Repetition Rate	5-100 Hz	5-100 Hz	5-100 Hz	5-100 Hz	1 Hz	1 Hz	1 Hz
Patient ContactMaterials	Stand-off tip		Unknown.	Unknown.	Stand-off tip
How provided	Reusable:Non-sterile, reusable,cleanable, sterilizable tip		Unknown	Reusable:Non-sterile,reusable,cleanable,sterilizable tip	Reusable:Non-sterile, reusable, cleanable,sterilizable tip
Electrical Reqs	220-240 VAC, 50/60Hz		Unknown	120 V~, 60 Hz	220-240 VAC, 50/60Hz
SystemDimensions(W x D x H)	15.7 x 21.7 x 48.5 inches		Unknown	32 x13 x 14 inches	15.7 x 21.7 x 48.5 inches
System Weight	133 lbs		Unknown	38 lbs	133 lbs

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

	Q-Switched Module
Characteristic	K11Modified Alma LasersHarmony 1064nm (Nd:YAG)Module (Q-Switched)Alma Lasers, Inc.	K110370Q-Clear™ Nd:YAG LaserLight Age, Inc.	K072564Alma Lasers Harmony XL™Muli-Application PlatformAlma Lasers, Ltd.
Product CodeRegulation	General & Plastic SurgeryGEX, 21 CFR 878.4810	General & Plastic SurgeryGEX, 21 CFR 878. 4810	General & Plastic SurgeryGEX, 21 CFR 878. 4810
Treatment λ	1064 nm (Nd:YAG) -Q-Switched	1064 nm (Nd:YAG) - Q-Switched	1064 nm (Nd:YAG) -Q-Switched
Spot Size	2.5 mm & 3.5 mm dia.(1, 2, 3, 4, 5, 6 mm dia. for otherapplications)	2.5 mm & 3.5 mm dia.2.5 mm, 3.5 mm, 5 mm; (optional6 mm) dia. for other applications) ·	1, 2, 3, 4, 5, 6 mm dia.
Pulse Energy	400 mJ (for onychomycosis)(system range 400-1,200mJ/pulse)	400 mJ (for onychomycosis)**Level 1 = 350 mJ/pulseLevel 2 = 500 mJ/pulseLevel 3 = 600 mJ/pulseLevel 4 = 700 mJ/pulse	400-1,200 mJ/pulse
Pulse Duration	3 - 10 nsec(system up to 20 nsec)	3 - 10 nsec	20 nsec
Laser Power	Up to 6 W	Up to 6 W	0.4 - 6 W
Energy Density	7.5 J/cm² (3.5 mm dia. spot)(system range 7.5 - 450 J/cm²)	7.5 J/cm³ (3.5 mm dia. spot)	Up to 152 J/ cm²
Repetition Rate	3 - 5 Hz (for onychomycosis)(system range 1 - 5 Hz)	3 - 5 Hz (range 1 - 5 Hz)	1, 2, 5 Hz
Patient ContactMaterials	Stand-off tip	Image: Unknown	Stand-off tip
How provided	Reusable:Non-sterile, reusable,cleanable, sterilizable tip	Reusable:Non-sterile, reusable, cleanable,sterilizable tip	Reusable:Non-sterile, reusable,cleanable, sterilizable tip
Electrical Reqs	220-240 VAC, 50/60Hz	120 V~, 60 Hz	220-240 VAC, 50/60Hz
SystemDimensions(W x D x H)	15.7 x 21.7 x 48.5 inches	32 x13 x 14 inches	15.7 x 21.7 x 48.5 inches
System Weight	133 lbs	38 lbs	133 lbs

Rationale for Substantial Equivalence VII.

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (used with the Harmony XLTM Muli-Application Platform) share the same indications for use, device operation, overall technical and functional capabilities, and therefore are substantially equivalent to the predicate devices.

VIII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics demonstrates that the Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (used with the Harmony XL™ Muli-Application Platform) are substantially equivalent to the predicate devices for their intended uses.

{5}------------------------------------------------

IX. Conclusion

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (used with the Harmony XL™ Muli-Application Platform) were found to be substantially equivalent to the predicate devices for their intended uses.

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (used with the Harmony XL™ Muli-Application Platform)share the same indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate devices for their intended uses.

Premarket Notification, 510(k) Submission for: Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules for Podiatry and the Temporary Increase in Clear Nail

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine, with a bird-like figure above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 13, 2013

Alma Lasers, Inc. % Ms. Anne Worden Regulatory Consultant 485 Half Day Road, Suite 100 Buffalo Grove, Illinois 68900

Re: K113810

Trade/Device Name: Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules 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: PDZ, GEX Dated: December 21, 2011 Received: December 23, 2011

Dear Ms. Worden:

This letter corrects our substantially equivalent letter of March 08, 2012.

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. Iisting 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.

{7}------------------------------------------------

Page 2 - Ms. Anne Worden

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 vours. FOR

Peter D. Rumm -S

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

Enclosure

{8}------------------------------------------------

Indications for Use Statement

K11 3816 510(k) Number (if known):

Modified Alma Lasers Harmony 1064nm (Nd: YAG) Modules Device Name:

Indications for Use:

Intended Use

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are intended to be used with the Harmony XL™ Multi-Application Platform for use in aestheir, cosmetic, and surgical applications requiring the ablation, vaporization, excision, and photothermolysis applioans requiring the wordlines, top the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, oral surgery, ophthalmology (skin orormitolarings (12.17); i.oa.issarges) vi.onary/thoracic surgery, and urology for surgical and aesthetic applications.

Indications for Use

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Module handpieces (Long Pulsed and The Modifica Inna Bacers rearners-cooling) used with the Harmony XLTM Muli-Application Platform are indicated for use in:

Podiatry

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

Matrixectomy .
Periungual and subungual warts t
Plantar warts ●
Radical nail excision ●
Neuromas .

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (Long Pulsed and Q-The Modi are intended for use with the Harmony XL™ Multi-Application Platform for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

*** Continued on following page ***

Prescription Use(Part 21 CFR 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 Eyaluation &

(Division Sign-Off) (Division Sigh-On)
Division of Surgical, Orthopedic, Division of Suive Devices

510(k) Number. K113810

Page 1 of 3

Premarket Notification, 510(k) Submission for: Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules for Podiatry and the Temporary Increase in Clear Nail

{9}------------------------------------------------

Indications for Use Statement

K11 3 8/0 510(k) Number (if known):

Device Name: Modified Alma Lasers Harmony 1064nm (Nd: YAG) Modules

Indications for Use - Continued from previous page

The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) are indicated for treatment and clearance of.

Benign vascular lesions such as, but not limited to treatment of:
- A Port wine stains
- Hemangiomas A
- Warts A
- Superficial and deep telangiectasias (venulectasias) A
- Reticular veins (0.1-4.0 mm dia.) of the leg A
- A Rosacea
- A Venus lake
- A Leg veins
- Spider veins P
- Poikiloderma of Civatte D
- Angiomas A

Benign cutaneous lesions, such as, but not limited to:

A Warts
A Scars
A Striae
A Psoriasis

Benign pigmented lesions such as, but not limited to: . �

Lentigos (age spots) A
Solar lentigos (sun spots) A
Cafe-au-lait macules A
Seborrheic keratoses A
Nevi and nevus of Ota A

*** Continued on following page

Prescription Use (Part 21 CFR 801 Subpan D) Over-The-Counter Use (21 CFR 80) Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation

NexRPO

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number: K113810

Page 2 of 3

Premarket Notification, 510(k) Submission for Modified Alma Lasers Harmony 1064mm (Nd.YAG) Modules for Podiatry and the Temporary Increase in Clear Nail

{10}------------------------------------------------

Indications for Use Statement

K11 38 0 510{k) Number (if known):

Modified Alma Lasers Harmony 1064nm (Nd. YAG) Modules Device Name:

Indications for Use - Continued from previous page

Benign pigmented lesions continued: .
- Chloasma
- Verrucae
- Þ
- Keratoses A
- The removal of black, blue or green tattoos (significant reduction in the intensity of A black and /or blue/black tattoos).
- Plaques ·
Pigmented lesions to reduce lesion size, for patients with lesions that would potentially . benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The non-ablative treatment of facial wrinkles, such as, but not limited to: �
- Periocular wrinkles
  - Perioral wrinkles A
Laser skin resurfacing procedures for the treatment of: .
- A Acne scars
- A Wrinkles
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an ● integral part of the scar.
Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. ●

The 1064 nm Nd:YAG lascrs (Long Pulsed only, with and without contact-cooling) is indicated for:

Removal of unwanted hair, for stable long-term, or permanent, hair reduction through � selective targeting of melanin in hair follicles.
Removal or lightening of unwanted hair (with and without adjuvant preparation) .
Treatment of pseudofolliculitis barbae (PFB) ●

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (2) 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)

Neikep Oble. Locman
(Division Signer)

(Division Sign-Off) Division of Surgical. Orthopedic. and Restorative Devices

510(k) Number K1(3810
Page 3 of 3

Premarket Notification, 510(k) Submission for:-Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules for Podiatry and the Temporary Increase in Clear Nail

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.