(29 days)
Not Found
No
The document describes a laser and IPL system for soft tissue treatment and hair removal. There is no mention of AI or ML in the intended use, device description, or performance studies. The Skintel Reader is mentioned as an objective measurement tool for melanin content, but this does not imply AI/ML.
Yes
The device is described as being used for various medical treatments, including skin resurfacing, treatment of wrinkles, removal of unwanted hair, treatment of pigmented lesions, and relief of muscle and joint pain, which are all therapeutic applications.
No
The device is described as an "Aesthetic System" that delivers laser or intense pulsed light for various surgical and dermatological treatments, such as excision, incision, vaporization, coagulation of soft tissue, skin resurfacing, hair removal, and treatment of various skin conditions. These are all therapeutic or cosmetic procedures, not diagnostic ones. While the "Skintel Reader" component is mentioned for "examining skin melanin content for determining and setting a test spot starting fluence," this is for treatment parameters, not for diagnosing a medical condition.
No
The device description explicitly details hardware components like stacking modules, power supply, control electronics, chiller, heat exchanger, base module, handpieces, and a front panel monitor. The performance studies also focus on the sterilization of hardware components (focal guides).
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device as a laser system for surgical and dermatological procedures involving the excision, incision, vaporization, coagulation, and resurfacing of soft tissue. These are all procedures performed directly on the patient's body.
- IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform such tests on samples.
- Device Description: The device description details a system that delivers light energy to a target site on the patient, not a system for analyzing biological samples.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic testing, or any metrics typically associated with IVD performance (like sensitivity, specificity, etc.).
Therefore, the Palomar Icon® Aesthetic System and its handpieces are therapeutic and surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: 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 and superficial skin lesions.
The 2940 Fractional Ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.
The 1540 Fractional Non-ablative Laser and 2940 Fractional Abaltive Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrides, furrows, fine lines, textural irregularities, dyschromia and pigmend lesions.
The 1440 Fractional Non-ablative Laser Handpiece and 2940 Fractional Ablative Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularties, dyschromia and pigmented lesions.
The MaxIR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle 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 may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); 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/light treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (FFB).
The Max series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae, removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including port wine stains, hemangiomas, aniomas, telangectasias, rosacca, facial and leg veins. The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.
Product codes
ONG, GEX
Device Description
The Palomar Icon® Aesthetic System including attachable treatment handpieces is designed to deliver pulses of broadband incoherent or laser light to a predetermined target site. The Palomar Icon® Aesthetic System consists of three stacking modules that contain an internal power supply, control electronics, Chiller Module, Heat Exchanger Module, Base Module, remote interlock, emergency-off button, footswitch, power control, and front panel monitor with indicators. They system includes multiple treatment hadnpieces attached to the Base Module. Each Handpiece provides laser energy at a specific wavelength or Intense Pulsed Light (IPL) at a specific range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue includes skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands.
hypertrophic and keloid scars, facial and leg veins, skin
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
An Autoclave Sterilization Validation of the 10 x 10 and 6 x 6 Focal Guide Assemblies was conducted using Steam Sterilization Validation Procedure. The Focal Guides were originally factory-sterilized by gamma sterilization and the intent is to provide the device to the customer non-sterile, with instructions for on-site autoclave sterilization. The test articles, negative controls, and environmental controls all exhibited no growth G. stearothermophilus after being subjected to 3 half cycle rounds of the gravity cycle settings described in ETR-191, Autoclave Sterilization Validation of 2940 Handpiece Focal Guides, meeting an SAL of ≤10°. The test articles also passed validation of the specified dry time (15 minutes, minimum), as no residual moisture was detected after being subjected to the full gravity cycle settings. Functional testing shows that the sterilization does not affect the function of the device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization Validation: An Autoclave Sterilization Validation of the 10 x 10 and 6 x 6 Focal Guide Assemblies was conducted using Steam Sterilization Validation Procedure. The test articles, negative controls, and environmental controls all exhibited no growth G. stearothermophilus after being subjected to 3 half cycle rounds of the gravity cycle settings described in ETR-191, Autoclave Sterilization Validation of 2940 Handpiece Focal Guides, meeting an SAL of ≤10°. The test articles also passed validation of the specified dry time (15 minutes, minimum), as no residual moisture was detected after being subjected to the full gravity cycle settings. Functional testing shows that the sterilization does not affect the function of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, interconnected design. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is also in black and is evenly spaced around the perimeter of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2014
Cynosure Incorporated Ms. Allyson Connor Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886
Re: K142376
Trade/Device Name: Palomar Icon Aesthetic System 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: ONG, GEX Dated: August 25, 2014 Received: August 26, 2014
Dear Ms. Connor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142376
Device Name Palomar Icon Aesthetic System
Indications for Use (Describe)
Indications for Use (Describe)
The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: 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 and superficial skin lesions.
The 2940 Fractional Ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.
The 1540 Fractional Non-ablative Laser and 2940 Fractional Abaltive Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrides, furrows, fine lines, textural irregularities, dyschromia and pigmend lesions.
The 1440 Fractional Non-ablative Laser Handpiece and 2940 Fractional Ablative Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularties, dyschromia and pigmented lesions.
The MaxIR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle 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 may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); 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/light treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (FFB).
The Max series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and FORM FDA 3881 (1/14) Page 2 of 2
for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae, removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including port wine stains, hemangiomas, aniomas, telangiectasias, rosacea, facial and leg veins. The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.
3
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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4
510(k) Summary:
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 C.F.R. 807.92.
| 807.92(a)(1) - Submitter Information | |
|---|---|
| Name | Cynosure Inc. |
| Address | 5 Carlisle Road |
| Westford, MA 01886 | |
| Name of contact person | Allyson Connor |
| Telephone | 978-367-8736 |
| Fax number | 978-256-6556 |
| aconnor@cynosure.com | |
| Establishment Registration Number | 1222993 |
| Date prepared | 8/25/14 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietary name | Palomar Icon® Aesthetic System |
| Common or usual name | Light and Laser System |
| Classification name | Instrument, Surgical, Powered, laser |
| Classification panel | General and Plastic Surgery |
| Regulation | 878.4810 |
| Product Code(s) | GEX, ONG |
807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed
Palomar Icon® Aesthetic System, K110907
807.92(a)(4) - Device description
The Palomar Icon® Aesthetic System including attachable treatment handpieces is designed to deliver pulses of broadband incoherent or laser light to a predetermined target site. The Palomar Icon® Aesthetic System consists of three stacking modules that contain an internal power supply, control electronics, Chiller Module, Heat Exchanger Module, Base Module, remote interlock, emergency-off button, footswitch, power control, and front panel monitor with indicators. They system includes multiple treatment hadnpieces attached to the Base Module. Each Handpiece provides laser energy at a specific wavelength or Intense Pulsed Light (IPL) at a specific range.
807.92(a)(5) Intended use of the device
Indications for use
The 2940 Ablative Laser Handpiece is intended for use in surgical applications
requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth
tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: 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 and superficial skin lesions.
The 2940 Fractional Ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
5
The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue. skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.
The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.
The 1540 Fractional Non-ablative Laser and 2940 Fractional Abaltive Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The 1440 Fractional Non-ablative Laser Handpiece and 2940 Fractional Ablative Laser Handpiece combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularties, dyschromia and pigmented lesions.
The MaxIR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle 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. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); 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/light treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venous lake, facial and leg veins;
reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar, coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (PFB).
The Max series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae, removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction: treatment of benign pigmented lesions, including port wine stains, hemangiomas, aniomas, telangectasias, rosacca, facial and leg veins.
The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot staring fluence.
| | 2940 Fractional Ablative Laser Handpiece
(K110907) | 2940 Fraction Ablative Laser Handpiece
(Modified) |
|------------|-------------------------------------------------------|------------------------------------------------------|
| Parameter | Description | Description |
| Laser Type | Erbium: YAG (Er:YAG) | Erbium: YAG (Er:YAG) |
| Wavelength | 2940 nm | 2940 nm |
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
6
| Fluence
(J/cm2) | Optic | Energy
(mJ/mB) | Microbeam
Density | Pitch (distance
between
microcolumns) | Optic | Energy
(mJ/mB) | Microbeam Density | Pitch (distance
between
microcolumns) |
|--------------------------------------------|----------------------------------------------------------------------------------------|------------------------|----------------------|---------------------------------------------|----------------------------------------------------------------------------------------|------------------------|-------------------|---------------------------------------------|
| | Silver
(Groove
тм Optic) | 2-5.5
mJ/0.1mm | N/A | 1350 μm
(grooves) | Silver
(Groove
тм Optic) | 2-5.5
mJ/0.1mm | N/A | 1350 μm
(grooves) |
| | Blue 450
Fractional
Optic | 3-9 mJ | 469
mB/cm² | 450 μm | Blue 450
Fractional
Optic | 3-9 mJ | 469
mB/cm² | 450 μm |
| | Green
1200
Fractional | 8-24 mJ | 178
mB/cm² | 750 μm | Green
1200
Fractional | 8-24 mJ | 178
mB/cm² | 750 μm |
| | Red 140
Fractional | 3-9 mJ | 169
mB/cm² | 750 μm | Red 140
Fractional | 3-9 mJ | 169
mB/cm² | 750 μm |
| | Purple
Flatbeam | 25 J/cm² –
70 J/cm² | N/A | N/A | Purple
Flatbeam | 25 J/cm² –
70 J/cm² | N/A | N/A |
| Spot Size
(mm) and
Treatment
Zone | 6 x 6 mm and 10 x 10 mm, depending on the Optic Flatbeam:
2 mm | | | | 6 x 6 mm and 10 x 10 mm, depending on the Optic
Flatbeam: 2 mm | | | |
| Pulse Width
(ms) | .25, 3, 5 ms | | | | .25, 3, 5 ms | | | |
| Delivery
System | Microbeams of light transmitted via a microlens array in the
interchangeable Optic. | | | | Microbeams of light transmitted via a microlens array in
the interchangeable Optic. | | | |
| Actuator | Foot pedal | | | | | | | |
807.92(b)(1-2) Nonclinical tests submitted
Test
Sterilization Validation
807.92(b)(3) Conclusions drawn from non-clinical data
An Autoclave Sterilization Validation of the 10 x 10 and 6 x 6 Focal Guide Assemblies was conducted using Steam Sterilization Validation Procedure. The Focal Guides were originally factory-sterilized by gamma sterilization and the intent is to provide the device to the customer non-sterile, with instructions for on-site autoclave sterilization. The test articles, negative controls, and environmental controls all exhibited no growth G. stearothermophilus after being subjected to 3 half cycle rounds of the gravity cycle settings described in ETR-191, Autoclave Sterilization Validation of 2940 Handpiece Focal Guides, meeting an SAL of ≤10°. The test articles also passed validation of the specified dry time (15 minutes, minimum), as no residual moisture was detected after being subjected to the full gravity cycle settings. Functional testing shows that the sterilization does not affect the function of the device.
7