(139 days)
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The "Smart Clinic Software" is mentioned as being previously cleared, but its function is not described as involving AI/ML.
Yes.
The device's stated "Intended Use / Indications for Use" directly references "surgical applications requiring the ablation, vaporization, and coagulation of soft tissue" and lists numerous medical and aesthetic treatments for various conditions, indicating a therapeutic purpose. Additionally, the "Summary of Performance Studies" mentions "therapeutic" laser equipment.
No.
The device is intended for surgical applications involving ablation, vaporization, and coagulation of soft tissue, as well as cosmetic and aesthetic treatments and pain management. While it mentions "Diagnostic biopsies" under the SupErb 2940nm Applicator, its primary function is therapeutic and interventional, not to diagnose a disease or condition. The "Diagnostic biopsies" are likely a procedure performed using the device, not the device itself performing a diagnosis.
No
The device description explicitly states it is comprised of a console housing hardware components (power supply, electronics, user interface) and multiple physical applicators. While it includes "Smart Clinic Software," the core device is a hardware platform with software control.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses consistently describe surgical applications requiring ablation, vaporization, coagulation, resurfacing, and treatment of various soft tissues and lesions. These are all procedures performed on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The description highlights it as a Class II Medical Device for dermatologic, aesthetic procedures and pain management. It describes a platform with applicators that deliver energy to the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on safety standards for medical electrical equipment and laser equipment, biological evaluation of medical devices, and software validation. The animal studies are related to tissue response to the laser treatment, not diagnostic accuracy.
In summary, the Alma Harmony is a therapeutic and surgical device that acts directly on the patient's body, which is the opposite of an In Vitro Diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Alma Harmony is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).
Clear Skin Pro 1540nm Applicator:
The ClearSkin Pro 1540nm is indicated for : Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
SupErb 2940nm Applicator:
The 2940 nm Er.Y AG Laser Module handard and scanner accessory tips (with and without contactcooling) is indicated for use in soft tissue (skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers.
General Surgery: Surgical incision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated.
Genitourinary: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar, lesions, polyps, and familiar polyps of the colon.
Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.
Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy.
Otothrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyns, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology : Treatment of: Soft tissue surrounding the eye and orbit.
Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy.
Clear Lift Pro Q-Switched Cr: Nd: YAG 1064 / 532 nm Applicator
1064mm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks.
532 nm mode is indicated for tattoo removal including red, blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, spider nevi and the treatment of benign pigmented lesions including Café-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532mm mode is also indicated for incision, ablation and vaporization of soft tissue in general dermatology.
ClearVas Nd:YAG 1064nm
For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stams, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
Treatment of wrinkles.
Removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
The ClearVas Nd: YAG 1064nm is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Iris VL / PL Applicator:
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.
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 benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI).
Iris Dye VL / Dye SVL Applicator:
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V).
Iris SHR Applicator:
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. 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
Iris Acne Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology.
The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for:
The treatment of moderate inflammatory acne vulgaris.
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
The treatment of cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI).
Iris NIR Applicator: Intended to emit energy in the infra-red 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 muscular back pain.
Iris Diode Applicator
The Iris diode is intended for use for vascular lesions, spider naevi, teleangiectass, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ILY, ONF, OUG
Device Description
The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It has 10 applicators that are attached to the console, which can be selected for use in treatment through the user interface.
In addition, this submission will add the Smart Clinic Software that was previously cleared in the Soprano Titanium (K210371).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, glands, external genitalia, urethra, anus, penis, scrotum, vulvar, colon, cervix, endometrium, oral, glossal, ear, nose, throat, eye, orbit, foot (plantar), face, body.
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)
The following performance data was provided in support of the substantial equivalence determination:
IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance.
IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility.
IEC 60601-2-22 Test for Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment.
ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.
Software verification and validation testing was conducted, and documentation provided as recommended by the FDA's "Guidance for the Content of Premarket Submissions Contained in Medical Devices.
Chronic animal studies were performed for the ClearSkin Pro 1540nm applicator. Histology was collected at immediate post 1,3, 7, 14, -day post, and 21-day post treatment on 3 porcine and showed healing at the 21-day point and the SupErb 2940 nm Applicator Histology was collected at immediate post, 1,3, 7day post, and14-day post treatment on 3 porcine and showed healing at the 3-day point.
Based on the above performance as documented in this application, the subject device was found to have a safety and effectiveness profile that is similar to the predicate devices. Safety is supported by performance testing as well as the animal study.
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.
K230308, K203441, K072564, K170850
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 8, 2024
Alma Lasers, Inc. Jessica Rivera-Montejo Director - Regulatory Affairs and Quality 485 Half Day Road #100 Buffalo Grove, Illinois 60089
Re: K233024
Trade/Device Name: Alma Harmony 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: GEX, ILY, ONF, OUG Dated: September 22, 2023 Received: September 22, 2023
Dear Jessica Rivera-Montejo:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tanisha L. Hithe Tanisha L. s 2024.02.08 Hithe -S 13:44:30 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233024
Device Name Alma Harmony
Indications for Use (Describe)
Intended Use:
The Alma Harmony is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).
Clear Skin Pro 1540nm Applicator:
The ClearSkin Pro 1540nm is indicated for : Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
SupErb 2940nm Applicator:
The 2940 nm Er.Y AG Laser Module handard and scanner accessory tips (with and without contactcooling) is indicated for use in soft tissue (skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers.
General Surgery: Surgical incision, vaporization, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated.
Genitourinary: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar, lesions, polyps, and familiar polyps of the colon.
Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.
Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy.
Otothrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyns, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology : Treatment of: Soft tissue surrounding the eye and orbit.
Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy.
Clear Lift Pro Q-Switched Cr: Nd: YAG 1064 / 532 nm Applicator
1064mm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks.
4
532 nm mode is indicated for tattoo removal including red, blue and green inks, for the treatment of benign vascular lesions including telangiectasias, spider angiomas, spider nevi and the treatment of benign pigmented lesions including Café-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532mm mode is also indicated for incision, ablation and vaporization of soft tissue in general dermatology.
ClearVas Nd:YAG 1064nm
For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stams, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
Treatment of wrinkles.
Removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
The ClearVas Nd: YAG 1064nm is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Iris VL / PL Applicator:
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.
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 benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations. Use on all skin types (Fitzpatrick I- VI).
Iris Dye VL / Dye SVL Applicator:
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V).
Iris SHR Applicator:
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. 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
Iris Acne Applicator:
Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical special and plastic surgery and dermatology.
The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for:
The treatment of moderate inflammatory acne vulgaris. FORM FDA 3881 (6/20)
5
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
The treatment of cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI).
Iris NIR Applicator: Intended to emit energy in the infra-red 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 muscular back pain.
Iris Diode Applicator
The Iris diode is intended for use for vascular lesions, spider naevi, teleangiectass, red superficial veins of the legs and face, pigmented lesions (e.g. cafe-au-lait stains, lentigo), hemangiomas, port wine stains, rosacea.
| 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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6
Section 7 510(k) Summary Alma Harmony K233024
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
I. Submitter Information [21 CFR 807.92(a) (1)]
| Owner Name | Alma Lasers Inc. |
|---|---|
| Address | 485 Half Day Rd. Suite 100 |
| Buffalo Grove, IL 60089 | |
| Contact Person | Jessica Rivera-Montejo |
| 224-377-2000- phone | |
| Jessica.rivera-montejo@almalasers.com | |
| Summary Preparation Date | February 4, 2024 |
II. Name of device [21 CFR 807.92 (a) (2)]
| Common Device Name(s) and
Regulatory Class | Product
Code(s) | Classification Panel | Regulation |
|----------------------------------------------------------------------------------------------------|--------------------|---------------------------------------|-------------------|
| Laser Surgical Instrument for use in
general and plastic surgery and in
dermatology Class II | GEX | General & Plastic
Surgery Panel 79 | § 21 CFR 878.4810 |
| Lamp, Infrared Therapeutic Class II | ILY | General & Plastic
Surgery Panel 79 | § 21 CFR 890.5500 |
| Powered Light Based Non-
Laser Surgical Instrument
with thermal effect | ONF | General & Plastic
Surgery Panel 79 | § 21 CFR 878.4810 |
| Medical Device Data System | OUG | General Hospital,
Panel 80 | § 21 CFR 880.6310 |
III. Predicate Device table by Applicator
| Applicator | Predicate
K Number | Predicate Name | Reference K
Number | Reference
Name |
|-------------------------|-----------------------|------------------------|-----------------------|-------------------|
| Iris SHR | K230308 | Alma Harmony | N/A | N/A |
| ClearSkin Pro
1540nm | K203441 | Hybrid ProScan
1570 | N/A | N/A |
| SupErb 2940nm | K072564 | Er:YAG Laser | N/A | N/A |
7
| Applicator | Predicate
K Number | Predicate Name | Reference K
Number | Reference
Name |
|----------------------------------------------|-----------------------|----------------|-----------------------|-------------------|
| | | Module | | |
| ClearLift Pro Q-Switch (1064nm
and 532nm) | K170850 | Alma Q | N/A | N/A |
| ClearVas Nd:YAG
1064nm | K170850 | Alma Q | K231054 | Wontech |
| Previously cleared
applicators | | | | |
| Iris VL/PL | K230308 | Alma Harmony | N/A | N/A |
| Iris Dye VL / SVL | K230308 | Alma Harmony | | |
| Iris Acne | K230308 | Alma Harmony | | |
| Iris NIR | K230308 | Alma Harmony | | |
| Iris Diode Laser | K230308 | Alma Harmony | | |
In addition, this submission will add the Smart Clinic Software. This software was previously cleared in the Alma Titanium K230371.
IV. Intended use of device and Indications for Use [21 CFR 807.92(a) (5)]
Intended Use:
The Alma Harmony is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including aesthetic surgery (dermatology and plastic surgery).
Indications for use:
ClearSkin Pro 1540nm applicator
The ClearSkin Pro 1540 nm is indicated for: Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
SupErb 2940 nm Applicator
The 2940 nm Er:YAG Laser Module handpiece with standard and scanner accessory tips (with and without contact-cooling) is indicated for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
Dermatology and Plastic Surgery: Skin resurfacing, Treatment of wrinkles, Epidermal nevi, Telangiectasia, Spider veins, Actinic chelitis, Keloids, Verrucae, Skin tags, Anal tags, keratoses, Scar revision (including acne scars), Debulking benign tumors, Debulking cysts, Superficial skin lesions, Diagnostic biopsies, Decubitus ulcers.
8
K233024
General Surgery: Surgical incision/excision, ablation, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation, and/or vessel coagulation may be indicated.
Genitourinary: Treatment of: Lesions of the external genitalia, urethra and anus, penis, scrotum, and urethra (includes condyloma acuminate, giant perineal condyloma, and verrucous carcinoma), vulvar. lesions, polyps, and familiar polyps of the colon.
Gynecology: Treatment of: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.
Oral/Maxiofacial: Treatment of: Benign oral tumors, oral and glossal lesions, and gingivectomy.
Otorhrynolaringology / Head and Neck (ENT): Treatment of: Ear, nose and throat lesions, polyps, cysts, hyperkeratosis, Excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology: Treatment of: Soft tissue surrounding the eye and orbit.
Podiatry: Treatment of: Warts, plantar verrucae, large mosaic verrucae, Matrixectomy.
Clear Lift Pro Q-Switched Cr: Nd: YAG 1064 / 532 nm Applicator
1064nm mode is indicated for the removal or lightening of unwanted facial or body hair, for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery, benign pigmented lesions (dermal melanocytosis) and tattoo removal for dark and blue inks.
532 nm mode is indicated for tattoo removal including red, blue and light blue and green inks, for the treatment of benign vascular lesion s including telangiectasias, spider angiomas, cherry angiomas, spider nevi and the treatment of benign pigmented lesions including Café-au-lait birthmarks, solar lentigines, Becker's nevi, freckles nevus spilus and nevus of ota. 532nm mode is also indicated for incision, excision, ablation and vaporization of soft tissue in general dermatology.
ClearVas Nd: YAG 1064 nm Applicator
For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
Treatment of wrinkles.
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Removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
The ClearVas ND:YAG 1064nm is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin.
Iris VL / PL Applicator:
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.
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 benign cutaneous vascular lesions including 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).
Iris Dye VL / Dye SVL Applicator:
The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including 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 skin types (Fitzpatrick I-V).
Iris SHR Applicator:
The Advanced Fluorescence Technology (AFT) 650-950 nm handpiece (with and without contact-cooling) is indicated for: The treatment of tattoos, the treatment of moderate inflammatory acne vulgaris, the treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait, the treatment of cutaneous lesions including warts, scars and striae, the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. 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
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Iris Acne Applicator:
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,
The Advanced Fluorescence Technology (AFT) 420-950 nm Acne Module Applicator (with and without contact-cooling) is indicated for:
The treatment of moderate inflammatory acne vulgaris
The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
The treatment of cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
Use on all skin types (Fitzpatrick I-VI)
Iris NIR Applicator:
Intended to emit energy in the infra-red spectrum to provide topical heating for the purpose of elevating the tissue temperature.
For the temporary relief of minor muscle pain and joint 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 muscular back pain.
Iris Diode Applicator
The Iris diode is intended for use for vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of the legs and face, pigmented lesions (e.g. cafeau-lait stains, lentigo), hemangiomas, port wine stains, rosacea.
V. Device Description [21 CFR 807.92(a) (4)]
The Alma Harmony is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic, aesthetic procedures and pain management procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It has 10 applicators that are attached to the console, which can be selected for use in treatment through the user interface.
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In addition, this submission will add the Smart Clinic Software that was previously cleared in the Soprano Titanium (K210371).
VI. Summary of technological characteristics of the device compared to the predicate [21 CFR 807.92(a)(6)]
The subject Harmony system shares with the predicate devices the same underlying technology and presents nearly identical technological characteristics. Both systems use laser, IPL and Near InfraRed (NIR) energy delivered to the skin surface via applicators.
The subject Alma Harmony is substantially equivalent to the previously cleared predicate devices with respect to hardware and software, principle of operation and product design.
Comparison of the ClearSkin Pro 1540nm and the Hybrid ProScan
| Device Trade Name | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| ClearSkin Pro | Harmony ClearSkin | ||
| Pro | Hybrid | ||
| ProScan/HyLight – | |||
| K203441 | |||
| Wavelength (nm) | 1540 nm | 1570 nm | The subject device's wavelength is |
| similar to the predicate and is | |||
| supported by the histology study. | |||
| Energy range per pulse per | |||
| microbeam (mJ/Pixel) | |||
| 7x7 | 6-82 mJ/Pixel | 1-144 mJ/Pixel | It is within the predicate range, |
| and it is supported in the histology | |||
| study. | |||
| Microbeam diameter (Pixel) | |||
| include pic [mm] | |||
| 7X7 | 1.27mm | 1mm | The proposed device's spot size |
| does not raise new concerns for | |||
| safety and effectiveness, and it is | |||
| supported in the histology study. | |||
| Spacing between the micro | |||
| beam centers [mm] | |||
| 7X7 | 1.33mm | 1.8mm | It is supported in the histology |
| study and does not raise new | |||
| concerns for safety and | |||
| effectiveness. | |||
| Pulse Width (milliseconds) | 3 | 0.4-30 | It is within the predicate range, |
| and it is supported in the histology | |||
| study. | |||
| Pulse Repetition Rate (Hz) | 1-3 | 1-5 | The PR range is within the range |
| of the predicate device. | |||
| Cooling | Yes | Yes | Same |
| Device Trade Name | Subject Device | Predicate Device | Comparison |
| SupErb | Harmony SupErb | Er:YAG Laser Module | |
| K072564 | |||
| Wavelength (nm) | 2940 nm | 2940 nm | Same |
| Energy range per pulse per | |||
| microbeam (mJ/Pixel) | |||
| 7x7 | 4-73 mJ/Pixel | 4-51 mJ/Pixel | The proposed device's energy |
| range does not raise new concerns | |||
| for safety and effectiveness, and it | |||
| is supported in the histology study. | |||
| 7 × 1 | 29-100 mJ/Pixel | 4-51 mJ/Pixel (7x7) | This tip(7x1) is the same as the 7x7 |
| technology. Same tip with one row. | |||
| The proposed device's energy | |||
| range does not raise new concerns | |||
| for safety and effectiveness.. It is | |||
| supported in the histology study | |||
| Microbeam diameter (Pixel) | |||
| include pic [mm] | |||
| 7x7 | 0.7mm | 0.7mm | Same |
| 7 × 1 | 0.7mm | 0.7mm | Same |
| Spacing between the micro | |||
| beam centers [mm] | |||
| 7x7 | 1.3mm | 1.1mm | Does not raise new concerns for |
| safety and effectiveness. | |||
| 7 × 1 | 1.2mm | 1.3mm | Does not raise new concerns for |
| safety and effectiveness. | |||
| Focus beam diameter (non- | |||
| Fractional) | 1mm – 6mm | 1mm - 6mm | Same |
| Energy range per pulse per Spot | |||
| Size [mJ/pulse] for the non- | |||
| Fractional Focus Beam | |||
| 1mm | 200-1400 | 100-1400 | Within the range of the predicate |
| device. | |||
| 2mm | 200-1400 | N/A | The corresponding lower fluence |
| for the 2mm spot size does not | |||
| raise new concerns regarding | |||
| safety and effectiveness when | |||
| compared to the 1mm spot size. | |||
| 3mm | 200-1400 | N/A | The corresponding lower fluence |
| for the 3mm spot size does not | |||
| Device Trade Name | Subject Device | Predicate Device | Comparison |
| SupErb | Harmony SupErb | Er:YAG Laser Module | |
| K072564 | raise new concerns regarding | ||
| safety and effectiveness. | |||
| 4mm | 200-1400 | 100-1400 | Within the range of the predicate |
| device. | |||
| 5mm | 200-1400 | N/A | The corresponding lower fluence |
| for the 5mm spot size does not | |||
| raise new concerns regarding | |||
| safety and effectiveness. | |||
| 6mm | 200-1400 | N/A | The corresponding lower fluence |
| for the 6mm spot size does not | |||
| raise new concerns regarding | |||
| safety and effectiveness. | |||
| 8mm | 100-250 | N/A | The corresponding lower fluence |
| for the 8mm spot size does not | |||
| raise new concerns regarding | |||
| safety and effectiveness. | |||
| Pulse Width (ms) | 0.25-1.5 | 1-2 | The proposed device's PW does not |
| raise new concerns for safety and | |||
| effectiveness | |||
| Pulse Repetition Rate (Hz) | 1mm-6mm: 2-6 | ||
| 8mm: 20 @ 0.18ms | 2,5 | Higher rep rate for subject device is | |
| in-motion at a lower fluence. | |||
| The proposed device's RR does not | |||
| raise new concerns for safety and | |||
| effectiveness. | |||
| Cooling | Yes | Yes | Same |
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Comparison of the SupErb 2940nm to the Er:YAG Laser Module
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Comparison of the ClearLift Pro(532nm) to the Alma Q (532nm)
| Device Trade Name | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| ClearLift Pro | Harmony ClearLift Pro | Alma Q K170850 | |
| Wavelength (nm) | 532 nm | 532 nm | Same |
| Spot Size | 2mm-10mm | 2mm-8mm | The lower fluence for the 9mm and |
| 10mm spot sizes does not raise new | |||
| concerns regarding safety and | |||
| effectiveness. | |||
| Energy range per pulse per Spot | |||
| Size [mJ/pulse] | |||
| 2mm | 400 | 50-450 |
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| Device Trade Name | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| ClearLift Pro | Harmony ClearLift Pro | Alma Q K170850 | |
| 3mm | 400 | 50-450 | Within predicate range. |
| 4mm | 400 | 50-450 | |
| 5mm | 400 | 50-450 | |
| 6mm | 400 | 50-450 | |
| 7mm | 400 | 50-450 | |
| 8mm | 400 | 350-700 | |
| 9mm | 400 | N/A | Compared to the 2mm-8mm spot |
| sizes, the corresponding lower | |||
| fluence does not raise new | |||
| concerns for safety and | |||
| effectiveness. | |||
| 10mm | 400 | N/A | Compared to the 2mm-8mm spot |
| sizes, the corresponding lower | |||
| fluence does not raise new concerns | |||
| for safety and effectiveness. | |||
| Focus beam diameter | 2mm – 10mm | 2mm – 8mm | Compared to the 2mm-8mm spot |
| sizes, the corresponding lower | |||
| fluence does not raise new concerns | |||
| for safety and effectiveness. | |||
| Pulse Width (nsec) | 10nsec | 7nsec | Device PW does not raise new |
| concerns for safety and | |||
| effectiveness. | |||
| Pulse Repetition Rate (Hz) | 1-6 | 1, 2, 5, 10 | It is within the predicate range. |
| Cooling | Yes | Yes | Same |
Comparison of the ClearLift Pro (1064nm)
| Device Trade Name | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| ClearLift Pro (1064nm) | Harmony ClearLift Pro | Alma Q K170850 | |
| Wavelength (nm) | 1064 nm | 1064 nm | Same |
| Spot Size (mm) | 2-10mm | 1-8mm | The lower fluence for the 9mm and |
| 10mm spot sizes does not raise new | |||
| concerns regarding safety and | |||
| effectiveness | |||
| Energy range per pulse per Spot | |||
| Size [mJ/pulse] | |||
| 2mm | 400-1600 | 200-2000 | Within predicate range. |
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| Device Trade Name | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| ClearLift Pro (1064nm) | Harmony ClearLift Pro | Alma Q K170850 | |
| 3mm | 400-1600 | 200-2000 | |
| 4mm | 400-1600 | 200-2000 | |
| 5mm | 400-1600 | 200-2000 | |
| 6mm | 400-1600 | 200-2000 | |
| 7mm | 400-1600 | 200-2000 | |
| 8mm | 400-1600 | 200-2000 | |
| 9mm | 400-1600 | N/A | The lower fluence for the 9mm and |
| 10mm spot sizes does not raise new | |||
| concerns regarding safety and | |||
| effectiveness. | |||
| 10mm | 400-1600 | N/A | The lower fluence for the 9mm and |
| 10mm spot sizes does not raise new | |||
| concerns regarding safety and | |||
| effectiveness. | |||
| Focus beam diameter (mm) | 2mm – 10mm | 2mm – 8mm | |
| Pulse Width (milliseconds) | 10nsec | 7nsec | The device's PW does not raise new |
| concerns for safety and effectiveness. | |||
| Pulse Repetition Rate (Hz) | 1-6 | 1, 2, 5, 10 | Within the predicate range. |
| Cooling | Yes | Yes | Same |
Comparison of the ClearVas to the Alma Q K170850
| | Subject
Device | Predicate
Device | Reference
Device | Comparison |
|---------------------------------------------------------|---------------------|---------------------|---------------------|-------------------------------------------------------------|
| ClearVas | Harmony
ClearVas | Alma Q
K170850 | Wontech
K231054 | |
| Wavelength (nm) | 1064 nm | 1064 nm | 1064 nm | Same |
| Spot Size | 2mm-8mm | 3mm-8mm | 2-12mm | Within reference predicate range. |
| Fluence range per
pulse
per Spot Size
[J/cm^2] | | | | |
| 2mm | 200-500 | N/A | 2-300 | Does not raise new concerns for safety
and effectiveness |
| 3mm | 200-400 | 80-500 | 2-300 | Within predicate range. |
| 4mm | 50-170 | N/A | 2-300 | Within reference predicate range. |
| 5mm | 50-170 | 30-180 | 2-300 | Within predicate range. |
| 6mm | 50-170 | N/A | 2-300 | Within reference predicate range. |
| 7mm | N/A | 14-92 | 2-300 | Subject device does not offer 7mm
spot size. |
| 8mm | 2-7 | 7-58 | 4-7 | Within reference predicate range, |
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| | Subject
Device | Predicate
Device | Reference
Device | Comparison |
|-------------------------------|---------------------|---------------------|---------------------|-----------------------------------|
| ClearVas | Harmony
ClearVas | Alma Q
K170850 | Wontech
K231054 | |
| | | | | when use In-Motion. |
| Focus beam
Diameter (mm) | 2mm – 8mm | 3mm – 8mm | 2mm-12mm | Within reference predicate range. |
| Pulse Width
(milliseconds) | 0.7-45ms | 0.5 – 60ms | Max. 60 ms | Within range of the predicate. |
| Pulse Repetition
Rate (Hz) | 1,10 | 1,2,3,5 | Max. 10 Hz | Within reference predicate range. |
| Cooling | Yes | Yes | Yes | Same |
Comparison of the Iris SHR to the previously cleared Iris SHR
| Device Trade Name | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Iris SHR | Harmony Iris SHR 650- | ||
| 950nm | Iris SHR 650-950nm | ||
| K230308 | |||
| Wavelength | 650-950 nm (HR/SHR) | 650-950 nm (HR/SHR) | Same |
| Energy Density | |||
| (Fluence) J/cm² | SHR: 3-7 | ||
| HR: 5-20 | SHR: 3-7 | ||
| HR: 5-20 | Same | ||
| Spot Size | 6.4 cm2 | 3 cm2 | The increased spot size does not raise |
| new concerns for safety and | |||
| effectiveness. | |||
| Pulse Width (ms) | 30,40,50 msec: | ||
| HR (Stationary) | |||
| 8 msec: SHR | |||
| (In-Motion) | 30,40,50 msec: HR | ||
| (Stationary) | |||
| 8 msec: SHR (In-Motion) | Same | ||
| Rep Rate (Hz) | 0.5 and 3 | 0.5 and 3 | Same |
| Mode | Stationary and In Motion | Stationary and In Motion | Same |
| Cooling | Yes | Yes | Same |
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| Device Trade Name | Current
Iris VL / PL -540 nm -950 nm | Previously cleared
VL / PL - 540 nm -950 nm | Comparison |
|--------------------------------|-----------------------------------------|------------------------------------------------|------------|
| Iris VL / PL | Harmony Iris VL / PL | K230308 | |
| Wavelength | 540-950nm | 540-950nm | Same |
| Energy Density (Fluence) J/cm2 | 5-30 | 5-30 | Same |
| Spot Size | 3 cm2 | 3 cm2 | Same |
| Pulse Width | 10,12,15 mSec | 10,12,15 mSec | Same |
| Rep Rate | 0.67 Hz | 0.67 Hz | Same |
| Mode | Stationary | Stationary | Same |
| Cooling | Yes | Yes | Same |
Comparison of the Iris VL / PL to the previously cleared VL / PL
Comparison of the Iris Dye VL/SVL to the previously cleared Iris Dye VL / SVL
| Device Trade Name | Current
Iris Dye VL /
Dye SVL
500 nm -600
nm | Previously Cleared
Iris Dye VL / Dye SVL
500 nm -600 nm | Comparison |
|--------------------------------|----------------------------------------------------------|---------------------------------------------------------------|------------|
| Iris Dye VL / Dye SVL | Harmony Iris Dye
VL/SVL | K230308 | |
| Wavelength | 500-600nm | 500-600nm | Same |
| Energy Density (Fluence) J/cm² | Dye VL : 5-15
Dye SVL: 1-4 | Dye VL : 5-15
Dye SVL: 1-4 | Same |
| Spot Size | 3 cm2 | 3 cm2 | Same |
| Pulse Width (ms) | 10,12,15 | 10,12,15 | Same |
| Rep Rate (Hz) | VL – 0.5
SVL – 3 | VL – 0.5
SVL – 3 | Same |
| Mode | Stationary | Stationary | Same |
| Cooling | Yes | Yes | Same |
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| Device Trade Name | Current Iris HR Mode
650-950 nm | Previously Cleared
HR 650-950 nm | Comparison |
|-----------------------------------|------------------------------------|-------------------------------------|------------|
| Iris HR Mode
650-950 nm | Harmony Iris HR | K230308 | |
| Wavelength | 650-950 nm (HR) | 650-950 nm (HR) | Same |
| Energy Density (Fluence)
J/cm² | HR: 5-20 | HR: 5-20 | Same |
| Spot Size | 6.4 cm2 | 6.4 cm2 | Same |
| Pulse Width (ms) | 30,40,50 msec) | 30,40,50 msec) | Same |
| Rep Rate (Hz) | 0.5 | 0.5 | Same |
| Mode | Stationary | Stationary | Same |
| Cooling | Yes | Yes | Same |
Comparison of the Iris HR Mode to the previously cleared Iris HR Mode
Comparison of the Iris Acne to the previously cleared Iris Acne
| Device Trade Name | Current
Iris Acne 420-
950nm | Previously Cleared
Acne 420-950nm | Comparison |
|--------------------------------|------------------------------------|--------------------------------------|------------|
| Iris Acne 420-950nm | Harmony Iris Diode | K230308 | Same |
| Wavelength | 420-950nm | 420-950nm | Same |
| Energy Density (Fluence) J/cm² | 5-25 | 5-25 | Same |
| Spot Size | 6.4 cm2 | 6.4 cm2 | Same |
| Pulse Width (ms) | 30-50msec | 30-50msec | Same |
| Rep Rate (Hz) | 1 | 1 | Same |
| Mode | Stationary | Stationary | Same |
| Cooling | Yes | Yes | Same |
Premarket Notification, Traditional 510(k)
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Comparison of the Iris NIR to the Previously Cleared Iris NIR
| Device Trade Name | Current
Iris NIR 1300nm | Previously Cleared
NIR 1300nm | Comparison |
|-------------------|-----------------------------|----------------------------------|------------|
| Iris NIR | Harmony Iris NIR | K230308 | |
| Wavelength | 1300nm | 1300nm | Same |
| Energy Density | 15w-25w | Up to 25W | Same |
| Spot Size | 6.4 cm2 | 6.4 cm2 | Same |
| Pulse Width | CW | CW | Same |
| Mode | CW Stamping | CW Stamping | Same |
| Cooling | Yes | Yes | Same |
Comparison of the Iris Diode Laser to the Previously Cleared Iris Diode Laser
| Device Trade
Name | Current
Iris Diode -520nm | Previously Cleared
Iris Diode -520nm | Comparison |
|-----------------------------------|------------------------------|-----------------------------------------|------------|
| Iris Diode - 532 | Harmony Iris Diode | K230308 | |
| Wavelength | 520nm | 520nm | Same |
| Energy Density
(Fluence) J/cm2 | 16-40 J/cm2 | 16-40 J/cm2 | Same |
| Spot Size | 0.5-2mm | 0.5-2mm | Same |
| Pulse Width | 1-100ms | 1-100ms | Same |
| Rep Rate | 1-10hz | 1-10hz | Same |
| Mode | Stamping and Motion | Stamping and
Motion | Same |
| Cooling | No | No | Same |
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Discussion and summary of technological characteristics:
Based on the summary of technological characteristics of the Alma Harmony in comparison to the predicates, the proposed modifications do not raise new types of considerations for safety and effectiveness compared to the predicate devices as seen in the tables above.
VII. Performance Testing [21 CFR 807.92(b)(1)]
The following performance data was provided in support of the substantial equivalence determination:
IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance.
IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility.
IEC 60601-2-22 Test for Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment.
ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.
Software verification and validation testing was conducted, and documentation provided as recommended by the FDA's "Guidance for the Content of Premarket Submissions Contained in Medical Devices.
Chronic animal studies were performed for the ClearSkin Pro 1540nm applicator. Histology was collected at immediate post 1,3, 7, 14, -day post, and 21-day post treatment on 3 porcine and showed healing at the 21-day point and the SupErb 2940 nm Applicator Histology was collected at immediate post, 1,3, 7day post, and14-day post treatment on 3 porcine and showed healing at the 3-day point.
Based on the above performance as documented in this application, the subject device was found to have a safety and effectiveness profile that is similar to the predicate devices. Safety is supported by performance testing as well as the animal study.
VIII. Clinical Data [21 CFR 807.92(b) (2)]
Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission.
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IX. Conclusions Safety and Effectiveness SE [21 CFR 807.92(b) (3)]
The Alma Harmony device that is the subject of this 510k pre-market notification is the same or similar in design, intended use, principles of operation, and technological characteristics, compared to the predicate devices. Differences in the subject devices output parameters do not raise new types of questions with regards to safety and effectiveness, and performance testing and histology data provided in this 510k support that the device can be used safely and effectively for the proposed indications for use. The Alma Harmony device that is the subject of this 510K is considered to be substantially equivalent to the predicate devices.