(30 days)
No
The document describes a multi-application laser and IPL system for dermatological procedures. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the different handpieces, wavelengths, filters, and treatment tips.
Yes
The device is indicated for various medical conditions such as benign epidermal lesions, cutaneous lesions, benign cutaneous vascular lesions, acne, vascular lesions, and treatment of pigmented lesions, which aligns with the definition of a therapeutic device.
No
The device description and intended uses clearly state that it is a multi-application, multi-technology platform for aesthetic and dermatological skin procedures (treatments), not for diagnosis. The listed indications for use are all conditions that are treated by the device (e.g., benign epidermal lesions, hair removal, vascular lesions), not conditions that are identified or assessed by the device.
No
The device description clearly outlines multiple hardware components including handpieces, filters, lightguides, and treatment tips, in addition to software.
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 are all related to aesthetic and dermatological skin procedures using light and laser energy. These procedures are performed directly on the patient's skin for treatment purposes.
- Device Description: The device is described as a multi-application, multi-technology platform with handpieces that deliver light and laser energy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body to gain information about a person's health. This device operates directly on the patient's skin for therapeutic and aesthetic purposes.
N/A
Intended Use / Indications for Use
The subject Stellar M22 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
- The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:
- Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and o ephelides (freckles)
- Cutaneous lesions, including warts, scars and striae O
- Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, O truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
- Removal of unwanted hair and to effect stable long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
- Mild to moderate inflammatory Acne (Acne vulgaris) o
- The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is ● indicated for:
- The coagulation and hemostasis of vascular lesions and soft tissue, including the O treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
- The removal of unwanted hair and to effect table long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
- The non-ablative treatment of facial wrinkles o
- . ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for:
- Use in dermatological procedures requiring fractional skin resurfacing and O
coagulation of soft tissue
- Use in dermatological procedures requiring fractional skin resurfacing and O
The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated ● for:
- Removal of dark tattoos O
- o Treatment of pigmented lesions
*Note
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
Product codes
GEX, ONF, ONG
Device Description
The subject Stellar M22 for Intense Pulsed Light (IPL) and Laser System is a multi-application, multitechnology platform with four (4) available treatment handpieces:
- Stellar Intense Pulsed Light (IPL) handpiece; ●
- . Multi-Spot Nd:YAG laser handpiece;
- ResurFX non-ablative laser handpiece: ●
- Q-Switched Nd:YAG laser handpiece. ●
The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems:
- The Stellar IPL handpiece has nine (9) different filters available: Cut-off filters of 515, . 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530-650& 900-1200 nm. Further, the IPL handpiece has three (3) Sapphire Cool LightGuides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6 mm diameter.
- The Multi-Spot Nd:YAG handpiece has three (3) different LightGuides available in sizes . of: 2mm x 4mm, 6 mm, and 9 mm.
- The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips
- . The Q-Switched Nd:YAG handpiece has both disposable and gold plated metal treatment tips available. The disposable treatment tips and metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.
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)
The following tests were performed to validate the modifications to the device:
- Design verification and validation testing .
- Risk analysis activities in compliance with ISO 14971 ●
- Electrical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2
- . IPL compatibility testing as required to conform with IEC 60601-2-57
- . Software verification and validation
Performance data demonstrates that the Stellar M22 for Intense Pulsed Light (IPL) and Laser system is as safe and effective as M22 System.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
Lumenis Ltd. % Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004
Re: K193500
Trade/Device Name: Stellar M22 for Intense Pulsed Light (IPL) and Laser 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: GEX, ONF, ONG Dated: December 17, 2019 Received: December 17, 2019
Dear Jonathan Kahan:
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. 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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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). 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-device-advice-comprehensive-regulatoryassistance/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.
Jessica Mavadia-Shukla Acting 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
2
| Indications for Use Statement | |
|---|---|
| ------------------------------- | -- |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
| See PRA Statement on last page |
|---|
| --------------------------------------------------------------------------------------------------------- |
| 510(k) Number (if known) | K193500 |
|---|---|
| Device Name | Stellar M22 for Intense Pulsed Light (IPL) and Laser system |
| Indications for Use (Describe) |
The subject Stellar M22 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
- The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:
- Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and o ephelides (freckles)
- Cutaneous lesions, including warts, scars and striae O
- Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, O truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
- Removal of unwanted hair and to effect stable long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
- Mild to moderate inflammatory Acne (Acne vulgaris) o
- The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is ● indicated for:
- The coagulation and hemostasis of vascular lesions and soft tissue, including the O treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
- The removal of unwanted hair and to effect table long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
- The non-ablative treatment of facial wrinkles o
- . ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for:
- Use in dermatological procedures requiring fractional skin resurfacing and O
3
coagulation of soft tissue
The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated ● for:
- Removal of dark tattoos O
- o Treatment of pigmented lesions
*Note
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
C)
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
Page 1 of 1 FDA
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510(k) SUMMARY
Stellar M22 for Intense Pulsed Light (IPL) and Laser System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam Industrial Park Yokneam 2069204, Israel
Phone: +972-4-9599000 Facsimile: +972-4-9599230
Contact Person: Shlomit Segman, RA Senior Manager
Date Prepared: December 17, 2019
Name of the device:
Stellar M22 for Intense Pulsed Light (IPL) and Laser system
Classification Name:
Powered Laser Surgical Instrument
Regulation Class:
Class II
Product Code:
GEX (21 C.F.R. § 878.4810)
Subsequent Product Codes:
ONF, ONG
Predicate Device:
M22 System (K170060)
Intended Use
The Lumenis Stellar M22 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
5
- The Stellar Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:
- Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and o ephelides (freckles)
- Cutaneous lesions, including warts, scars and striae O
- Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, O truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
- Removal of unwanted hair and to effect stable long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
- Mild to moderate inflammatory Acne (Acne vulgaris) o
- The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is ● indicated for:
- The coagulation and hemostasis of vascular lesions and soft tissue, including the O treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
- The removal of unwanted hair from all skin types, and to effect table long term, or o permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- The non-ablative treatment of facial wrinkles o
- ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: ●
- Use in dermatological procedures requiring fractional skin resurfacing and o coagulation of soft tissue
- . The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for:
- Removal of dark tattoos O
- Treatment of pigmented lesions o
*Note: Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
6
Device Description
The subject Stellar M22 for Intense Pulsed Light (IPL) and Laser System is a multi-application, multitechnology platform with four (4) available treatment handpieces:
- Stellar Intense Pulsed Light (IPL) handpiece; ●
- . Multi-Spot Nd:YAG laser handpiece;
- ResurFX non-ablative laser handpiece: ●
- Q-Switched Nd:YAG laser handpiece. ●
The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems:
- The Stellar IPL handpiece has nine (9) different filters available: Cut-off filters of 515, . 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530-650& 900-1200 nm. Further, the IPL handpiece has three (3) Sapphire Cool LightGuides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6 mm diameter.
- The Multi-Spot Nd:YAG handpiece has three (3) different LightGuides available in sizes . of: 2mm x 4mm, 6 mm, and 9 mm.
- The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips
- . The Q-Switched Nd:YAG handpiece has both disposable and gold plated metal treatment tips available. The disposable treatment tips and metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.
Technological Characteristics
The intended use and indications for use of the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems are the same as the predicate device. In addition, the same technological characteristics and principles of operation apply for the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems and the predicate device.
Comparison table of the technological characteristics of the Stellar M22 for Intense Pulsed Light (IPL) and Laser System compared to the predicate device is provided below:
| | Stellar M22
(subject device) | Cleared M22 and
ResurFX Systems
(K170060) | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Principle of Operation | Selective
photothermolysis | Selective
photothermolysis | Same as predicate |
| Device Components | System console
Four (4) available
treatment handpieces:
• Stellar Intense
Pulsed Light
(IPL) | System console
Four (4) available
treatment handpieces:
• Universal
Intense Pulsed
Light (IPL) | Same as predicate |
| Monitor Display | Multi-Spot
Nd:YAG laser
handpiece Q-Switched
Nd:YAG laser
handpiece ResurFX non-
ablative laser
module and
handpiece 12" | Multi-Spot
Nd:YAG laser
handpiece Q-Switched
Nd:YAG laser
handpiece ResurFX non-
ablative laser
module and
handpiece 8.4" | Substantially
equivalent |
| Software operating
system | Windows 10 Embedded | Windows CE 5 | Substantially
equivalent |
| IPL Handpiece | | | |
| Wavelength | 400-1200 nm | 400-1200 nm | Same as predicate |
| Pulse duration
(msec) | Up to 20 msec – single
pulse | Up to 20 msec – single
pulse | Same as predicate |
| Operational
wavelengths | The IPL handpiece
comes with 9 filters for
various wavelengths: Cut-off filters: 515,
560, 590, 615, 640,
695, 755 nm Acne Filter (Notch
filter 400-600 and
800-1200) Vascular Filter
(Notch filter 530-650
& 900-1200) | The IPL handpiece
comes with 10 filters for
various wavelengths: Cut-off filters: 515,
560, 590, 615, 640,
695, 755 nm Acne Filter (Notch
filter 400-600 and
800-1200) Vascular Filter
(Notch filter 530-650
& 900-1200) KTP filter (525-585
nm) | Same as predicate
but without the
KTP filter |
| SapphireCool
LightGuides | Height: 55 mm | Height: 40 mm | Substantially
equivalent – minor
modification to
dimension |
| Spot sizes (cm²) | 8x15 mm (1.20 cm2)
15x35 mm (5.25 cm2)
6 mm round (0.3 cm2) | 8x15 mm (1.20 cm2)
15x35 mm (5.25 cm2)
6 mm round (0.3 cm2) | Same as predicate |
| Maximum Fluence | Up to 35 or 56 J/cm²,
upon tip size | Up to 35 or 56 J/cm²,
upon tip size | Same as predicate |
| Pulse Rate [Hz] | Up to 1 Hz | Up to 1 Hz | Same as predicate |
| Multiple Sequential
Pulsing | Yes, 1, 2, and 3 pulses,
varying fluence per
pulse (AOPT mode) | Yes, 1, 2, and 3 pulses,
varying fluence per
pulse (AOPT mode) | Same as predicate |
| Contact sapphire
cooling temperature | 0 to10 °C (Rectangular)
0 to 15°C (Round) | 4 to 10°C | Substantially
Equivalent - |
| | | | |
| Treatment screens | Treatment present with
additional basic
treatment presets | Treatment present | Substantially
equivalent - Minor
software update to
platform |
| LightGuide
recognition | Yes | N/A | Substantially
Equivalent -
Addition of minor
Hardware and
software features
to recognize
connected fibers |
| Multi-Spot Nd:YAG Handpiece | | | |
| Operational
Wavelength | 1064 nm | 1064 nm | Same as predicate |
| Spot sizes (mm) | 2x4, 6, 9 | 2x4, 1.5, 6, 9 | Substantially
Equivalent |
| Maximum Fluence | Up to 225 J/cm² upon tip
size (due to removal of
the 1.5 mm tip) | Up to 600 J/cm² upon tip
size | Substantially
Equivalent |
| Pulse rate | Up to 1 Hz | Up to 1 Hz | Same as predicate |
| Multiple Sequential
Pulsing | 1, 2, and 3 | 1, 2, and 3 | Same as predicate |
| Contact sapphire
cooling temperature | -4 to 10 °C | 4 to 10°C | Substantially
Equivalent |
| ResurFX Handpiece | | | |
| Operational
Wavelength | 1565 nm | 1565 nm | Same as predicate |
| Maximum Energy | Up to 40 or 70 mJ per
micro-beam, upon tip | Up to 40 or 70 mJ per
micro-beam, upon tip | Same as predicate |
| Type of Laser | Er:Glass Fiber-laser with
scanner | Er:Glass Fiber-laser with
scanner | Same as predicate |
| Tip treatment width | 18 mm Sapphire Cool
Tip
18 mm Precision Tip | 18 mm Sapphire Cool
Tip
18 mm Precision Tip | Same as predicate |
| Scanner | Dual axis scanner | Dual axis scanner | Same as predicate |
| Scanner shapes | Line, square, rectangle,
circle, donut, hexagon,
vertical line, and vertical
rectangle | Line, square, rectangle,
circle, donut, hexagon,
vertical line, and vertical
rectangle | Same as predicate |
| Treatment screens | Treatment present with
additional basic
treatment presets | Treatment present | Substantially
equivalent - Minor
software update to
platform |
| Q-Switched Nd:YAG Handpiece | | | |
| Operational
Wavelength | 1064 nm | 1064 nm | Same as predicate |
| Spot sizes (mm, diameter) | Disposable tips: 2.0, 2.5, 3.5 and 5.0 mm
Gold plated metal tips:
2.0, 2.5, 3.5, 4.0, 5.0, 6.0 and 8.0 mm | Disposable tips: 2.0, 2.5, 3.5 and 5.0 mm
Gold plated metal tips:
2.0, 2.5, 3.5, 4.0, 5.0, 6.0 and 8.0 mm | Same as predicate |
| Maximum Fluence | Up to 14 J/cm², upon tip size | Up to 14 J/cm², upon tip size | Same as predicate |
| Pulse Duration (nsec) | 6-8 | 6-8 | Same as predicate |
| Pulse Rate (Hz) | 0.5-5.0 | 0.5-5.0 | Same as predicate |
| Software | | | |
| Remote access capabilities | Yes | N/A | Substantially
Equivalent -
Addition of minor
software features
for internal
company use |
7
8
9
Performance Data
The following tests were performed to validate the modifications to the device:
- Design verification and validation testing .
- Risk analysis activities in compliance with ISO 14971 ●
- Electrical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2
- . IPL compatibility testing as required to conform with IEC 60601-2-57
- . Software verification and validation
Conclusions
Stellar M22 for Intense Pulsed Light (IPL) and Laser system has the same intended use and similar indications, principles of operation, and technological characteristics as M22 System. The minor differences in the Stellar M22 for Intense Pulsed Light (IPL) and Laser system's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the Stellar M22 for Intense Pulsed Light (IPL) and Laser system is as safe and effective as M22 System. Thus, the Stellar M22 for Intense Pulsed Light (IPL) and Laser system is substantially equivalent to its predicate devices.