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

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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Stellar M22 for Intense Pulsed Light (IPL) and Laser system. This document outlines the device's intended use, technological characteristics, and compares it to a predicate device (M22 System, K170060) to establish substantial equivalence.

However, the summary does not include specific acceptance criteria or details of a study that proves the device meets those criteria in a quantitative sense as often seen in clinical performance studies with specific endpoints. Instead, it describes "Performance Data" in the context of design verification, compliance with standards, and software validation to demonstrate that modifications to the device do not raise new questions of safety or effectiveness compared to the predicate device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not detailed in this type of regulatory submission, as it focuses on demonstrating substantial equivalence rather than proving a specific diagnostic accuracy or treatment efficacy de novo.

Below is a summary based on the information provided, with "N/A" for information not present in the document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a quantitative table format that measures specific performance metrics against a defined threshold. Instead, it focuses on demonstrating that the Stellar M22 device's modifications do not introduce new safety or effectiveness concerns compared to its predicate. The "reported device performance" is framed in terms of functional verification and compliance with standards.

Acceptance Criteria Category	Reported Device Performance/Compliance
Design Verification & Validation	Tests performed to validate modifications to the device (specifics not detailed)
Risk Analysis	Compliance with ISO 14971
Electrical Safety	Compliance with IEC 60601-1
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2
IPL Compatibility	Compliance with IEC 60601-2-57
Software Verification & Validation	Tests performed (specifics not detailed)
Technological Characteristics Equivalence	The device's technological characteristics (wavelength, pulse duration, maximum fluence, etc.) are substantially equivalent to the predicate, with minor modifications not raising new safety/effectiveness questions (see detailed comparison table in the source text).

2. Sample size used for the test set and the data provenance

N/A - The document describes general performance data related to engineering verification and validation, and compliance with standards. It does not refer to a clinical "test set" with a specific sample size of patients or images for diagnostic or therapeutic performance evaluation. The data provenance is also not specified in terms of country of origin or retrospective/prospective nature, as this is not a clinical study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A - No clinical "test set" requiring ground truth established by experts is described in this regulatory submission for substantial equivalence.

4. Adjudication method for the test set

N/A - No clinical "test set" or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A - This document does not describe an MRMC comparative effectiveness study or involve AI assistance for human readers. The device is a laser and IPL system for dermatological procedures, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A - This device is a medical instrument (laser and IPL system), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A - As there is no clinical "test set" for performance evaluation in the context of diagnostic accuracy or treatment efficacy against a reference standard, the concept of ground truth in that sense is not detailed. The performance data focuses on engineering and safety compliance.

8. The sample size for the training set

N/A - The document does not describe a "training set" in the context of machine learning or AI algorithms.

9. How the ground truth for the training set was established

N/A - Not applicable, as there is no mention of an AI training set or related ground truth.

Summary

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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.

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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

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Indications for Use Statement
-------------------------------	--

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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 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

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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.

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.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (1/14)

Page 1 of 1 FDA

PSC Publishing Services (301) 443-6

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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:

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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.

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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 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 andResurFX Systems(K170060)	Comparison
Principle of Operation	Selectivephotothermolysis	Selectivephotothermolysis	Same as predicate
Device Components	System consoleFour (4) availabletreatment handpieces:• Stellar IntensePulsed Light(IPL)	System consoleFour (4) availabletreatment handpieces:• UniversalIntense PulsedLight (IPL)	Same as predicate
Monitor Display	Multi-SpotNd:YAG laserhandpiece Q-SwitchedNd:YAG laserhandpiece ResurFX non-ablative lasermodule andhandpiece 12"	Multi-SpotNd:YAG laserhandpiece Q-SwitchedNd:YAG laserhandpiece ResurFX non-ablative lasermodule andhandpiece 8.4"	Substantiallyequivalent
Software operatingsystem	Windows 10 Embedded	Windows CE 5	Substantiallyequivalent
IPL Handpiece
Wavelength	400-1200 nm	400-1200 nm	Same as predicate
Pulse duration(msec)	Up to 20 msec – singlepulse	Up to 20 msec – singlepulse	Same as predicate
Operationalwavelengths	The IPL handpiececomes with 9 filters forvarious wavelengths: Cut-off filters: 515,560, 590, 615, 640,695, 755 nm Acne Filter (Notchfilter 400-600 and800-1200) Vascular Filter(Notch filter 530-650& 900-1200)	The IPL handpiececomes with 10 filters forvarious wavelengths: Cut-off filters: 515,560, 590, 615, 640,695, 755 nm Acne Filter (Notchfilter 400-600 and800-1200) Vascular Filter(Notch filter 530-650& 900-1200) KTP filter (525-585nm)	Same as predicatebut without theKTP filter
SapphireCoolLightGuides	Height: 55 mm	Height: 40 mm	Substantiallyequivalent – minormodification todimension
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 SequentialPulsing	Yes, 1, 2, and 3 pulses,varying fluence perpulse (AOPT mode)	Yes, 1, 2, and 3 pulses,varying fluence perpulse (AOPT mode)	Same as predicate
Contact sapphirecooling temperature	0 to10 °C (Rectangular)0 to 15°C (Round)	4 to 10°C	SubstantiallyEquivalent -

Treatment screens	Treatment present withadditional basictreatment presets	Treatment present	Substantiallyequivalent - Minorsoftware update toplatform
LightGuiderecognition	Yes	N/A	SubstantiallyEquivalent -Addition of minorHardware andsoftware featuresto recognizeconnected fibers
Multi-Spot Nd:YAG Handpiece
OperationalWavelength	1064 nm	1064 nm	Same as predicate
Spot sizes (mm)	2x4, 6, 9	2x4, 1.5, 6, 9	SubstantiallyEquivalent
Maximum Fluence	Up to 225 J/cm² upon tipsize (due to removal ofthe 1.5 mm tip)	Up to 600 J/cm² upon tipsize	SubstantiallyEquivalent
Pulse rate	Up to 1 Hz	Up to 1 Hz	Same as predicate
Multiple SequentialPulsing	1, 2, and 3	1, 2, and 3	Same as predicate
Contact sapphirecooling temperature	-4 to 10 °C	4 to 10°C	SubstantiallyEquivalent
ResurFX Handpiece
OperationalWavelength	1565 nm	1565 nm	Same as predicate
Maximum Energy	Up to 40 or 70 mJ permicro-beam, upon tip	Up to 40 or 70 mJ permicro-beam, upon tip	Same as predicate
Type of Laser	Er:Glass Fiber-laser withscanner	Er:Glass Fiber-laser withscanner	Same as predicate
Tip treatment width	18 mm Sapphire CoolTip18 mm Precision Tip	18 mm Sapphire CoolTip18 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 verticalrectangle	Line, square, rectangle,circle, donut, hexagon,vertical line, and verticalrectangle	Same as predicate
Treatment screens	Treatment present withadditional basictreatment presets	Treatment present	Substantiallyequivalent - Minorsoftware update toplatform
Q-Switched Nd:YAG Handpiece
OperationalWavelength	1064 nm	1064 nm	Same as predicate
Spot sizes (mm, diameter)	Disposable tips: 2.0, 2.5, 3.5 and 5.0 mmGold 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 mmGold 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	SubstantiallyEquivalent -Addition of minorsoftware featuresfor internalcompany use

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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.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.