(76 days)
Not Found
No
The document describes a laser system for various aesthetic and surgical applications. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The description focuses on the hardware components and the laser's intended uses.
Yes
The device is described as a laser system intended for specified medical treatments in various specialties, including the ablation, vaporization, excision, incision, and photothermolysis of soft tissue, as well as the treatment of conditions like onychomycosis, benign vascular and cutaneous lesions, and removal of unwanted hair, all of which are considered therapeutic applications.
No
The device uses laser energy for surgical and aesthetic applications, such as ablation, vaporization, and removal of unwanted tissue or hair, and has no stated diagnostic capabilities.
No
The device description clearly states it is a laser handpiece containing an optical bench that emits a high-power laser beam, which is a hardware component. It also mentions a handpiece housing, trigger, standoff-tip, umbilical cable, and module connector, all of which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a laser handpiece used with a platform for aesthetic, cosmetic, and surgical applications. It directly interacts with the patient's body (soft tissue, nails, skin) for treatment purposes (ablation, vaporization, excision, incision, photothermolysis, hair removal, wrinkle treatment, etc.).
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient. The device's function is based on applying laser energy to the body.
Therefore, the intended use and device description align with a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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
- 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)
Product codes (comma separated list FDA assigned to the subject device)
PDZ, GEX
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 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)
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K103626, K093547, K093545, K110370, K072564
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
:・
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
-
2
- 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.
3
| Long Pulsed Module | |||||||
|---|---|---|---|---|---|---|---|
| K1J | |||||||
| Modified Alma Lasers | |||||||
| Harmony 1064nm (Nd:YAG) | |||||||
| Module (Long Pulsed) | |||||||
| Alma Lasers, Inc. | K103626 | ||||||
| Cutera | |||||||
| GenesisPlus | |||||||
| Laser System | |||||||
| Cutera, Inc. | K093547 & | ||||||
| K093545 | |||||||
| PinPointeTM | |||||||
| FootLaserTM | |||||||
| (Model 6W, 30W, | |||||||
| 100W) | |||||||
| PinPointe USA & | |||||||
| Incisive, Inc. | K072564 | ||||||
| Alma Lasers Harmony XLTM Muli- | |||||||
| Application Platform | |||||||
| Alma Lasers, Ltd. | |||||||
| Characteristic | |||||||
| Product Code | |||||||
| Regulation | General & Plastic Surgery | ||||||
| GEX, 21 CFR 878.4810 | General & Plastic Surgery | ||||||
| GEX, 21 CFR 878.4810 | General & Plastic Surgery | ||||||
| GEX, 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 mm | ||||||
| dia. spot) | 30-450 | ||||||
| J/cm² | 30-150 | ||||||
| J/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 Contact | |||||||
| Materials | 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 | |||
| System | |||||||
| Dimensions | |||||||
| (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 | K11 | ||
| Modified Alma Lasers | |||
| Harmony 1064nm (Nd:YAG) | |||
| Module (Q-Switched) | |||
| Alma Lasers, Inc. | K110370 | ||
| Q-Clear™ Nd:YAG Laser | |||
| Light Age, Inc. | K072564 | ||
| Alma Lasers Harmony XL™ | |||
| Muli-Application Platform | |||
| Alma Lasers, Ltd. | |||
| Product Code | |||
| Regulation | General & Plastic Surgery | ||
| GEX, 21 CFR 878.4810 | General & Plastic Surgery | ||
| GEX, 21 CFR 878. 4810 | General & Plastic Surgery | ||
| GEX, 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 other | |||
| applications) | 2.5 mm & 3.5 mm dia. | ||
| 2.5 mm, 3.5 mm, 5 mm; (optional | |||
| 6 mm) dia. for other applications) · | 1, 2, 3, 4, 5, 6 mm dia. | ||
| Pulse Energy | 400 mJ (for onychomycosis) | ||
| (system range 400-1,200 | |||
| mJ/pulse) | 400 mJ (for onychomycosis)* | ||
| *Level 1 = 350 mJ/pulse | |||
| Level 2 = 500 mJ/pulse | |||
| Level 3 = 600 mJ/pulse | |||
| Level 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 Contact | |||
| Materials | 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 |
| System | |||
| Dimensions | |||
| (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
V
*** 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