BELLUS-Q

K253344 · Speclipse, Inc. · GEX · Nov 25, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K253344
• Device Name: BELLUS-Q
• Applicant: Speclipse, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 25, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BELLUS-Q, Q switched Nd:YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 1064 nm wavelength in Q-switched mode: - Removal of dark (black, blue, brown) tattoo ink - Treatment of nevus of ota - Treatment of common nevi - Removal and lightening of unwanted hair - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Treatment of melasma - General dermatology indications: Incision, excision, ablation and vaporization of soft tissue 1064 nm wavelength in GENESIS mode: - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris 532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces): - Red, tan, purple and orange tattoo ink removal - Sky blue (light) tattoo ink removal - Green tattoo ink removal - Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus - Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi - Seborrheic Keratosis - Treatment of post-inflammatory hyperpigmentation - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Removal of epidermal pigmented lesions

Device Story

BELLUS-Q is a Q-switched Nd:YAG laser system for dermatological and surgical procedures. It utilizes a solid-state Nd:YAG medium (1064 nm) and KTP (532 nm) with optional dye handpieces (585/650 nm). The system delivers laser energy via an articulated arm to one of five handpieces (Zoom, Collimated, MLA, Dye). Operation modes include single pulse, PTP, 3-pulse, 6-pulse, and Genesis. The device leverages selective photothermolysis to target chromophores for coagulation, denaturation, or vaporization of tissue. Used in clinical settings by healthcare professionals, the system features a touch LCD monitor, footswitch, and safety interlocks. The provider selects parameters based on the target lesion or tissue; the laser energy is absorbed by the target, sparing surrounding tissue. Benefits include precise tissue treatment, lesion removal, and skin resurfacing.

Clinical Evidence

Bench testing only. Performance verified through testing of laser output energy, wavelength, repetition rate, spot size, pulse width, and beam output. Electrical safety and EMC compliance per IEC 60601-1, 60601-1-2, 60601-2-22, and 60825-1. Biocompatibility confirmed per ISO 10993-5, 10993-10, and 10993-23.

Technological Characteristics

Solid-state Nd:YAG laser; 1064 nm and 532 nm wavelengths (expandable to 585/650 nm via dye handpieces). Articulated arm delivery. Modes: single pulse, PTP, 3-pulse, 6-pulse, Genesis. Max fluence: 102 J/cm2 (1064 nm Genesis). Electrical safety: IEC 60601-1 (v3.2), 60601-1-2 (v4.1), 60601-2-22 (v4.0). Laser safety: IEC 60825-1 (v3.0). Biocompatibility: ISO 10993 series.

Indications for Use

Indicated for incision, excision, ablation, and vaporization of soft tissue in general dermatology and surgery; coagulation and hemostasis. Specific applications include tattoo removal (various colors), treatment of pigmented/vascular lesions (e.g., nevus of Ota, port wine stains, telangiectasias), hair removal/lightening, acne scar/wrinkle resurfacing, melasma, and inflammatory acne vulgaris. Applicable to various skin types.

Regulatory Classification

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.

Predicate Devices

• StarWalker (K202172)
• Pastelle Pro (K241527)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

November 25, 2025

SPECLIPSE. Inc.
% Janice Hogan
Partner
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia, Pennsylvania 19103

Re: K253344
Trade/Device Name: BELLUS-Q
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
Dated: September 30, 2025
Received: September 30, 2025

Dear Janice Hogan:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253344 - Janice Hogan
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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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K253344 - Janice Hogan
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K253344

Device Name
BELLUS-Q

Indications for Use (Describe)
BELLUS-Q, Q switched Nd:YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064 nm wavelength in Q-switched mode:
- Removal of dark (black, blue, brown) tattoo ink
- Treatment of nevus of ota
- Treatment of common nevi
- Removal and lightening of unwanted hair
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of melasma
- General dermatology indications: Incision, excision, ablation and vaporization of soft tissue

1064 nm wavelength in GENESIS mode:
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris

532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):
- Red, tan, purple and orange tattoo ink removal
- Sky blue (light) tattoo ink removal
- Green tattoo ink removal
- Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
- Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
- Seborrheic Keratosis
- Treatment of post-inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Removal of epidermal pigmented lesions

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (6/20)
Page 1 of 2
PSC Publishing Services [phone]

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (6/20)
Page 2 of 2

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510(k) Summary
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BELLUS-Q

1. Date Prepared [21 CFR 807.92(a)(1)]
Nov. 19, 2025

2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Manufacturer: SPECLIPSE, Inc.
- Address: #501, #502, #503, #504, #505, 232, Sandan-ro, Danwon-gu, Ansan-si, Gyeonggi-do, 15433, Republic of Korea
- Contact Name: Myung Seo Park
- Telephone No.: [phone]
- Email Address: [e-mail]
- Registration No.: TBD

3. Identification of Proposed Device(s) [21 CFR 807.92(a)(2)]
| 510(k) Number | K253344 |
| --- | --- |
| Trade/Device/Model Name | BELLUS-Q |
| Product Name | Nd:YAG Surgical Laser Equipment |
| Common Name | Laser Surgical Instrument |
| Regulation Name | Powered Laser Surgical Instrument |
| Regulation Number | 21 CFR 878.4810 |
| Classification Product Code | GEX |
| Device Class | II |
| 510(k) Review Panel | General & Plastic Surgery |

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510(k) Summary
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BELLUS-Q

# 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate device within this submission is shown as follow;

- Predicate device #1

| 510(k) Number | K202172 |
| --- | --- |
| Trade/Device/Model Name | StarWalker |
| Common Name | Laser Surgical Instrument |
| Device Classification Name | Powered laser surgical instrument |
| Regulation Number | 21 CFR § 878.4810 |
| Classification Product Code | GEX |
| Device Class | Class II |
| 510(k) Review Panel | General & Plastic Surgery |

- Predicate device #2

| 510(k) Number | K241527 |
| --- | --- |
| Trade/Device/Model Name | Pastelle Pro |
| Common Name | Laser Surgical Instrument |
| Device Classification Name | Powered laser surgical instrument |
| Regulation Number | 21 CFR § 878.4810 |
| Classification Product Code | GEX |
| Device Class | Class II |
| 510(k) Review Panel | General & Plastic Surgery |

These predicate devices have not been subject to a design-related recall.

# 5. Description of the Device [21 CFR 807.92(a)(4)]

The system consists of a power supply, laser resonator, touch LCD monitor, articulated arm, handpieces, foot switch, and laser protective eyewear. The system includes several safety features, including use of key switch, an interlock, emergency stop button, and need to press a footswitch in order to activate the laser. The main body transmits the laser energy through the articulating arm to the handpiece which is positioned above or in contact with the

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treatment area. Five different handpieces can be attached to the articulated arm, the Zoom handpiece, Collimated handpiece, MLA handpiece, 585 Dye handpiece, and the 650 Dye handpiece. In addition, the system can operate in different modes, including single pulse, PTP, 3-pulse, 6-pulse, and genesis modes. Each handpiece integrates and aiming beam that shows the treatment area.

The Nd:YAG laser surgical system utilizes a solid-state laser medium of Nd:YAG at 1064 nm and KTP at 532 nm. The 1064 nm and 532 nm wavelengths interact with targeted skin cells or tissues, primarily leveraging the Photothermolysis Effect in Q-switched nanosecond pulse modes. This selective photothermolysis mechanism enables controlled thermal absorption within target chromophores, leading to coagulation, denaturation, or vaporization of melanin-containing cells while preserving surrounding tissues. The laser energy is effectively absorbed by pigmented lesions, allowing for precise and efficient treatment in dermatological applications.

The system also supports Dye handpieces, which enable the use of 585 nm and 650 nm wavelengths by converting 532 nm light. These wavelengths have greater absorption for different specific pigment-related lesions, expanding the system's versatility in medical and aesthetic procedures.

## 6. Indications for Use [21 CFR 807.92(a)(5)]

BELLUS-Q, Q switched Nd:YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

- 1064 nm wavelength in Q-switched mode:
- Removal of dark (black, blue, brown) tattoo ink
- Treatment of nevus of ota
- Treatment of common nevi
- Removal and lightening of unwanted hair
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of melasma
- General dermatology indications: Incision, excision, ablation and vaporization of soft tissue

510(k) Summary
BELLUS-Q

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- 1064 nm wavelength in GENESIS mode:
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris

- 532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):
- Red, tan, purple and orange tattoo ink removal
- Sky blue (light) tattoo ink removal
- Green tattoo ink removal
- Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
- Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
- Seborrheic Keratosis
- Treatment of post-inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Removal of epidermal pigmented lesions

510(k) Summary
BELLUS-Q

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# 7. Substantial Equivalence

The subject device has a subset of the indications cleared for K202172, and all devices share the same intended use of laser use in dermatological surgical and aesthetic applications. The subject device has identical indications to predicate #1, in that it is a subset of the predicate device (it does not have the indications related to use in PICO mode). Predicate #2 has equivalent indications, although they do not match verbatim. In sum, the subject device has the same intended use as either of the predicates.

The technological characteristics between the subject and the predicate devices are similar. All devices have two primary wavelengths, 1064 and $532\mathrm{nm}$ . All devices have dye handpieces that can modify the $532\mathrm{nm}$ output to 585 or $650\mathrm{nm}$ (595 and $660\mathrm{nm}$ in K241527). All devices can be operated in various modes, including single pulse (termed Q-switched in K202172) and genesis (termed long pulsed in K202172). The subject device also contains additional modes that are equivalent to other modes available only in K241527, including PTP and multi-pulse modes. While the subject device has 3 and 6 multi-pulse mode options, K241527 has 2 and 3 multi-pulse options. The addition of a 6-pulse option does not raise different questions as the pulse energy remains within the cleared energy of Genesis mode. The predicates also have modes that are not part of the subject device – specifically, K202172 has PICO mode which uses pulse widths shorter than the subject device, and K241527 has DOE mode which treats a large, square area. The fact that the subject device does not include these modes does not raise any questions. Finally, the handpieces available in the subject device match those provided in K241527 and include Zoom, Collimation, MLA, and Dye, although the predicate also includes DOE handpiece.

[Table 3. Comparison of Proposed Device to Predicate Devices]

| | Proposed Device | Predicate Device #1 | Predicate Device #2 | Note |
| --- | --- | --- | --- | --- |
| K Number | K253344 | K202172 | K241527 | - |
| Manufacturer | SPECLIPSE, Inc. | Fotona d.o.o. | WON TECH Co., Ltd. | - |
| Device Name | BELLUS-Q | StarWalker | Pastelle Pro | - |
| Product Code | GEX | GEX | GEX | Identical |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |

510(k) Summary

BELLUS-Q

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| | Proposed Device | Predicate Device #1 | Predicate Device #2 | Note |
| --- | --- | --- | --- | --- |
| 510(k) Review Panel | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | Identical |
| Indications for Use | 1064 nm wavelength in Q-switched mode:
-Removal of dark (black, blue, brown) tattoo ink
-Treatment of nevus of ota
-Treatment of common nevi
-Removal and lightening of unwanted hair
-Skin resurfacing procedures for the treatment of acne scars and wrinkles
-Treatment of melasma
-General dermatology indications: Incision, excision, ablation and vaporization of soft tissue

1064 nm wavelength in GENESIS mode:
-Treatment of wrinkles
-Treatment of mild to moderate inflammatory acne vulgaris

532 nm wavelength in Q-switched mode (nominal | 1064 nm wavelength in Q-switched mode:
-Removal of dark (black, blue, brown) tattoo ink
-Treatment of nevus of ota
-Treatment of common nevi
-Removal and lightening of unwanted hair
-Skin resurfacing procedures for the treatment of acne scars and wrinkles
-Treatment of melasma
-General dermatology indications: Incision, excision, ablation and vaporization of soft tissue

1064 nm wavelength in long pulse mode:
-Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, | The Pastelle Pro system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064nm in nanosecond mode, including microbeam handpieces:
- Tattoo removal: dark ink (black, blue, and brown)-Removal of Nevus of Ota
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Treatment of Common Nevi
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of melasma | Identical (subset of predicate #1) |

510(k) Summary
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BELLUS-Q

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510(k) Summary
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BELLUS-Q

| | Proposed Device | Predicate Device #1 | Predicate Device #2 | Note |
| --- | --- | --- | --- | --- |
| | delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):
-Red, tan, purple and orange tattoo ink removal
-Sky blue (light) tattoo ink removal
-Green tattoo ink removal
-Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
-Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
-Seborrheic Keratosis
-Treatment of post-inflammatory hyperpigmentation
-Skin resurfacing procedures for the | including tanned skin
-Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
-Coagulation and hemostasis of soft tissue
-Treatment of wrinkles
-Treatment of mild to moderate inflammatory acne vulgaris
532nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):
-Red, tan, purple and orange tattoo ink removal
-Sky blue (light) tattoo ink removal
-Green tattoo itatoo ink removal | 1064nm in Genesis (long-pulse) mode:
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm with optional dye handpieces):
- Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of Lentigines
- Treatment of Café-au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory | |

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| | Proposed Device | Predicate Device #1 | Predicate Device #2 | Note |
| --- | --- | --- | --- | --- |
| | treatment of acne scars and wrinkles
-Removal of epidermal pigmented lesions | -Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
-Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
-Seborrheic Keratosis
-Treatment of post-inflammatory hyperpigmentation
-Skin resurfacing procedures for the treatment of acne scars and wrinkles
-Removal of epidermal pigmented lesions
532 nm wavelength in long pulse mode:
-Incision, ablation vaporization, coagulation and hemostasis of vascular lesions and soft tissue in various surgical | Hyperpigmentation
- Treatment of Becker's Nevi, Freckles, and Nevi spilus | |

510(k) Summary
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BELLUS-Q

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| | Proposed Device | Predicate Device #1 | Predicate Device #2 | Note |
| --- | --- | --- | --- | --- |
| | | areas. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
-The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia)

1064 nm wavelength in PICO mode:
-Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple
-Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
-Treatment of acne scars in Fitzpatrick Skin Types II-V
-Treatment of wrinkles as well as benign pigmented | | |

510(k) Summary
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BELLUS-Q

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| | Proposed Device | Predicate Device #1 | Predicate Device #2 | Note |
| --- | --- | --- | --- | --- |
| | | lesions in
Fitzpatrick Skin
Types I-IV

532 nm wavelength
in PICO mode:
-Tattoo removal in
Skin Types I - III
-Treatment of
benign pigmented
lesions in
Fitzpatrick Skin
Types I-IV | | |
| Laser Source | Nd:YAG | Nd:YAG | Nd:YAG | Identical |
| Wavelength | 532/1064 nm
585/650 nm with
dye convertible
handpieces | 532/1064 nm
585/650 nm with
dye convertible
handpieces | 532/1064 nm
595/660 nm with
dye convertible
handpieces | Identical to
predicate #1,
equivalent to #2 |
| Max. Fluence | **1064nm:**
Single: 48.00 J/cm2
Genesis: 102.00
J/cm2

**532nm:**
Single: 16.05 J/cm2 | - Not disclosed in
public documentation | **1064nm:**
48J/cm2

Genesis: 100J/cm2

**532nm:**
15J/cm2 | Max. Fluence
is equivalent
to predicate
#2 |
| Pulse Energy | **1064nm:**
Singe: Up to 1532 mJ
PTP: Up to 2019 mJ
3Pulse: Up to 2521
mJ
6Pulse: Up to 3016
mJ
Genesis: Up to 3299
mJ

**532nm:**
Single: Up to 509 mJ
PTP: Up to 505 mJ | **1064nm:**
Q-switched: Up to
1600 mJ

Long-Pulsed: Up to
15000 mJ (long
pulsed)
PICO Nd:YAG: Up to
800 mJ

**532nm:** | **1064nm:**
50 - 1,200 mJ
PTP: 600 - 2,000 mJ

Triple mode: 1,000 -
1400 mJ
2x PTP: 1,000 -
1400 mJ
Genesis: 100 -
5,000 mJ

**532 nm:**
30 - 500 mJ | **1064nm:**
Single: less than
predicate #1
PTP, multi-pulse, &
genesis (long
pulse): less than
genesis for
predicate #2

**532nm:**
Within range of
predicate #1 |

510(k) Summary
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BELLUS-Q

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| | Proposed Device | Predicate Device #1 | Predicate Device #2 | Note |
| --- | --- | --- | --- | --- |
| | 585nm: Up to 252mJ
650nm: Up to 153mJ | Q-switched: Up to 600 mJ
Long-Pulsed: Up to 2000 mJ
PICO KTP: Up to 300 mJ
585nm: Not disclosed in public documentation
650nm: Not disclosed in public documentation | 595 nm: 30 - 250 mJ
660 nm: 30 - 150 mJ | 585nm: Equivalent to predicate #2
650nm: Equivalent to predicate #2 |
| Pulse Width | 1064nm: 5-10 ns (Single, PTP, 3 Pulses, 6 Pulses mode)
60-300 μs (Genesis)
532nm: 5-10 ns (Single, PTP mode) | 1064nm: 5 - 20 ns (Q-switched)
600 - 5000 μs (long pulsed)
300 - 400 ps (PICO Nd:YAG)
532nm: 5 – 20 ns (Q-switched)
15-50ms (long pulsed)
300 - 400 ps (PICO KTP) | 1064nm: 5 – 12 ns
Up to 20ns (PTP/Triple/2X PTP): 80-300 μs (Genesis)
532nm: 5 – 12 ns | 1064nm: Equivalent to predicates #1 and #2
532nm: Equivalent to predicates #1 and #2 |
| Max. Repetition Rate (Hz) | 1064nm 15 Hz (all modes)
532nm 10 Hz (all modes) | 1064nm 0.5 - 15 Hz (Q-switched)
0.5 - 10 Hz (PICO Nd:YAG)
532nm 0.5 - 10 Hz (Q-switched) | 1064nm 1 - 10 Hz (all modes)
532 nm 1 - 10 Hz | 1064nm: Equivalent to predicate #1
532nm: Equivalent to predicates #1 and #2 |

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| | Proposed Device | Predicate Device #1 | Predicate Device #2 | Note |
| --- | --- | --- | --- | --- |
| | 585nm
1 Hz (all modes)

650nm
1 Hz (all modes) | 0.5 - 1 Hz (long pulsed)
0.5 - 8 Hz (PICO KTP) | 595 nm
1 - 5 Hz

660 nm
1 - 2 Hz | 585nm:
Equivalent to predicate #2

650nm:
Equivalent to predicate #2 |
| Spot Size | Zoom: 2-10 mm
Collimation: 8 mm
MLA: 4-9mm
Dye: 3mm | - Not disclosed in public documentation | Zoom: 2-10mm
Collimation: 7mm
MLA: 3-8mm
Dye: 3mm
DOE: 5mm x 5mm
~ 7mm x 7mm | Spot Size is similar to predicate #2 |

510(k) Summary

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# 8. Non-Clinical Test Summary

The 'BELLUS-Q' complies with voluntary standards for electrical safety, electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:

1) Electrical Safety, Electromagnetic Compatibility and Performance:

The 'BELLUS-Q' complies with the electrical safety and electromagnetic compatibility requirements established by the standards.

| Standards No. | Standards Organization | Standard Title | Version | Publication Year |
| --- | --- | --- | --- | --- |
| 60601-1 | IEC | Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance | 3.2 | 2020 |
| 60601-1-2 | IEC | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 4.1 | 2020 |
| 60601-2-22 | IEC | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | 4.0 | 2019 |
| 60825-1 | IEC | Safety of laser products – Part 1: Equipment classification and requirements | 3.0 | 2014 |

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2) Biocompatibility Testing

The 'BELLUS-Q' complies with the bio-compatibility requirements established by the standards.

| Standards No. | Standards Organization | Standard Title | Version | Publication Year |
| --- | --- | --- | --- | --- |
| 10993-5 | ISO | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | 3.0 | 2009 |
| 10993-10 | ISO | Biological evaluation of medical devices - Part 10: Tests for skin sensitization | 4.0 | 2021 |
| 10993-23 | ISO | Biological evaluation of medical devices - Part 23: Tests for irritation | 1.0 | 2021 |

3) Software Validation

The 'BELLUS-Q' contains Enhanced Documentation Level software. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance:

- The content of premarket submissions for software contained in medical devices, on June 14, 2023

4) Bench Testing

Bench testing of the laser output energy, wavelength, repetition rate, spot size, pulse width, and beam output was conducted to verify the device's performance and to demonstrate that it achieves its claimed performance. These results support the demonstration of substantial equivalence to the predicate device.

9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

There are no significant differences between the proposed device and the predicate devices K202172 and K241527 that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics.

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10. Conclusion [21 CFR 807.92(b)(3)]

In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, concludes that the 'BELLUS-Q' is substantially equivalent in safety and effectiveness to the predicate devices as described herein.

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