HELIOS 785 Pico (1754V2)

K243780 · Laseroptek Co., Ltd. · GEX · Feb 7, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K243780
• Device Name: HELIOS 785 Pico (1754V2)
• Applicant: Laseroptek Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 7, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

[Indications for use of Q-switched Nd:YAG Laser] 1064 nm(including RTP 1064 mode): - Incision, excision, ablation, vaporization of soft tissue for general dermatology - Removal or lightening of unwanted hair with or without adjuvant preparation - Treatment melasma - Treatment of Pigmented Lesions - nevus of ota - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Tattoo Removal - dark ink: black, blue and brown 532 nm: - Treatment of Vascular Lesions - port wine birthmarks - telangiectaias - spider angioma - cherry angioma - spider nevi - Treatment of Pigmented Lesions - café-au-lait birthmarks - solar lentiginos - senile lentiginos - becker's nevi - freckles - nevus spilus - nevus of ota - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Tattoo Removal - light ink: red, sky blue, green, tan, purple, and orange [Indications for use of FR mode in Nd:YAG Laser] - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofollicultis Barbae). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins - Coagulation and hemostasis of soft tissue - Treatment of wrinkles [Indications for use of Ti:Sapphire Laser] - Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 785nm: *Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously *

Device Story

HELIOS 785 Pico (1754V2) is a multi-wavelength laser system (1064nm, 532nm, 785nm) for dermatological procedures. Input: electrical energy converted to light via flashlamp pumping. Operation: Nd:YAG crystal generates 1064nm; KTP crystal converts to 532nm; Ti:Sapphire crystal generates 785nm. Modes include Q-switched (short pulses), RTP (Real Twin Pulse), and FR (Free Running). Output: laser energy delivered via articulated arm/handpiece. Used in clinical settings by physicians. Output allows tissue ablation, coagulation, hemostasis, and pigment/tattoo destruction. Benefits include versatile treatment of vascular/pigmented lesions, hair reduction, and skin resurfacing.

Clinical Evidence

Bench testing only. Evaluated for electrical safety (ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), risk management (ISO 14971), usability (IEC 60601-1-6), and surgical laser performance (IEC 60601-2-22).

Technological Characteristics

Laser system with Nd:YAG and Ti:Sapphire crystals. Wavelengths: 1064nm, 532nm, 785nm. Pulse durations: 5-10ns (Q-switched), 300us (FR mode). Max energy: 3.0J (FR mode). Beam delivery: Articulated arm. Cooling: Internal water-to-air heat exchanger. Power: 220-230V. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22.

Indications for Use

Indicated for soft tissue incision/excision/ablation/vaporization, hair removal/reduction, treatment of melasma, pigmented/vascular lesions, acne scars, wrinkles, and tattoo removal. Patient population includes all skin types (Fitzpatrick I-VI) for hair reduction; Fitzpatrick II-IV for specific tattoo removal. Contraindications include simultaneous use of Q-switched Nd:YAG and Ti:Sapphire lasers.

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

• HELIOS 785 Pico (1754V1) (K230373)
• Finebeam (K202288)

Submission Summary (Full Text)

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February 7, 2025

Laseroptek Co., Ltd. % Kim Do Hyun CEO BT Solutions, Inc. Unit 303, Gonghang-daero 337, Gangseo-gu Seoul, Seoul 07590 Korea, South

Re: K243780

Trade/Device Name: HELIOS 785 Pico (1754V2) 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: December 9, 2024 Received: December 9, 2024

Dear Kim Do Hyun:

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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by TANISHA - Digitally signed by L. HITHE -> 22:25:46 -05'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K243780

Device Name HELIOS 785 Pico (1754V2)

#### Indications for Use (Describe)

[Indications for use of O-switched Nd:YAG Laser]

1064 nm (including RTP 1064 mode):

- Incision, excision, ablation, vaporization of soft tissue for general dermatology
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Treatment melasma
- Treatment of Pigmented Lesions
- · nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
- dark ink: black, blue and brown

532 nm:

- Treatment of Vascular Lesions
- · port wine birthmarks
- · telangiectaias
- · spider angioma
- · cherry angioma
- · spider nevi
- Treatment of Pigmented Lesions
- · café-au-lait birthmarks
- · solar lentiginos
- · senile lentiginos
- · becker's nevi
- · freckles
- nevus spilus
- nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
- · light ink: red, sky blue, green, tan, purple, and orange

[Indications for use of FR mode in Nd:YAG Laser]

- Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofollicultis Barbae). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin

- Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins

- Coagulation and hemostasis of soft tissue
- Treatment of wrinkles
- [Indications for use of Ti:Sapphire Laser]

- Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.

785nm:

*Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously *

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)

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# 510(k) Summary K243780

### 1 General Information

| Applicant/Submitter: | Laseroptek Co., Ltd. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Hyundai I Valley 114,116,117,203,204, 31,<br>Galmachi-ro 244beon-gil, Jungwon-gu,<br>Seongnam-si, Gyeonggi-do, Republic of<br>Korea |
| Contact Person: | Do Hyun Kim, BT Solutions, Inc. |
| Address: | Unit 303, Gonghang-daero 337, Gangseo-gu<br>Seoul, 07590, Republic of Korea<br>Tel: [phone]<br>Email: [e-mail] |
| Preparation Date: | February 4, 2025 |

### 2 Device Name and Code

| Device Trade Name: | HELIOS 785 Pico |
|----------------------|---------------------------------------------------------------|
| Model Name: | 1754V2 |
| Common Name: | Q-switched Nd:YAG + Gain switched<br>Ti:sapphire Laser System |
| Classification Name: | Powered laser surgical instrument |
| Product Code: | GEX |
| Regulation Number: | 878.4810 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |

### 3 Technical Characteristics in Comparison to Predicate Devices

The HELIOS 785 Pico, is substantially equivalent to the following legally marketed predicate devices: HELIOS 785 Pico (1754V1) (K230373) and Finebeam (K202288);

| | Predicate Device (1) | Proposed Device |
|--------------------------------|----------------------|---------------------|
| 510(K) Number | K230373 | K243780 |
| Product Code | GEX | GEX |
| Classification /<br>Regulation | Class II/878.4810 | Class II/878.4810 |
| Manufacturer | Laseroptek Co.,Ltd. | Laseroptek Co.,Ltd. |

Table 1 Comparison of the proposed device to the primary predicate device

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## HELIOS 785 Pico(Model: 1754V2) 510(k) Summary K243780

| Device Name | HELIOS 785 Pico | HELIOS 785 Pico |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model No. | 1754V1 | 1754V2 |
| Intended Use /<br>Indications for<br>Use: | [Indication for use of Q-switched<br>Nd:YAG Laser]<br>- Incision, excision, ablation,<br>vaporization of soft tissue for<br>general dermatology (1064nm)<br>- Removal or lightening of<br>unwanted hair with or without<br>adjuvant preparation (1064nm)<br>- Tattoo Removal (1064nm,<br>532nm)<br>dark ink: blue and black<br>(1064nm)<br>light ink: red, sky blue, green<br>(532nm)<br>- Treatment of Vascular Lesions<br>(532nm)<br>port wine birthmarks<br>telangiectaias<br>spider angioma<br>cherry angioma<br>spider nevi<br>- Treatment of Pigmented Lesions<br>(1064nm, 532nm)<br>café-au-lait birthmarks (532nm)<br>solar lentiginos (532nm)<br>senile lentiginos (532nm)<br>becker's nevi (532nm)<br>freckles (532nm)<br>nevus spilus (532nm)<br>nevus of ota (1064nm)<br>[Indication for use of Ti:Sapphire<br>Laser]<br>- Removal of tattoos for<br>Fitzpatrick skin types II-IV to<br>treat the following tattoo colors:<br>green and blue. (785nm)<br>*Q-switched Nd:YAG Laser and<br>Ti:Sapphire Laser cannot be used<br>simultaneously.* | [Indications for use of Q-switched<br>Nd:YAG Laser]<br>1064 nm(including RTP 1064<br>mode):<br>- Incision, excision, ablation,<br>vaporization of soft tissue for<br>general dermatology<br>- Removal or lightening of<br>unwanted hair with or without<br>adjuvant preparation<br>- Treatment melasma<br>- Treatment of Pigmented Lesions<br>nevus of ota<br>- Skin resurfacing procedures for<br>the treatment of acne scars and<br>wrinkles<br>- Tattoo Removal<br>dark ink: black, blue and brown<br>532 nm:<br>- Treatment of Vascular Lesions<br>port wine birthmarks<br>telangiectaias<br>spider angioma<br>cherry angioma<br>spider nevi<br>- Treatment of Pigmented Lesions<br>café-au-lait birthmarks<br>solar lentiginos<br>senile lentiginos<br>becker's nevi<br>freckles<br>nevus spilus<br>- Skin resurfacing procedures for<br>the treatment of acne scars and<br>wrinkles<br>- Tattoo Removal<br>light ink: red, sky blue, green,<br>tan, purple, and orange |
| | | [Indications for use of FR mode<br>in Nd:YAG Laser]<br>- Removal of unwanted hair, for<br>stable long term or permanent<br>hair reduction and treatment of<br>PFB (Pseudofolliculitis Barbae).<br>The laser is indicated for all skin<br>types, Fitzpatrick I-VI, including<br>tanned skin<br>- Photocoagulation and<br>hemostasis of pigmented and<br>vascular lesions, such as but not<br>limited to port wine stains,<br>cherry angioma, Hemangiomas,<br>warts, telangiectasias, rosacea,<br>leg veins, and spider veins<br>- Coagulation and hemostasis of<br>soft tissue<br>- Treatment of wrinkles<br><br>[Indications for use of<br>Ti:Sapphire Laser]<br>785 nm:<br>- Removal of tattoos for<br>Fitzpatrick skin types II-IV to<br>treat the following tattoo colors:<br>green and blue.<br><br>*Q-switched Nd:YAG Laser and<br>Ti:Sapphire Laser cannot be used<br>simultaneously.* |
| Wavelength | 1064 mm, 532 mm, 785 mm | 1064 mm, 532 mm, 785 mm |
| Pulse Duration<br>(max) | 5-10 ns @ 1064 nm<br>5-10 ns @ 532 nm<br>600 ps @ 785 nm | 5-10 ns @ 1064 nm<br>5-10 ns @ 532 nm<br>600 ps @ 785 nm<br>5-10 ns @ RTP mode(1064nm)5)<br>300 us @ FR mode(1064 nm)5) |
| Pulse Energy<br>(max) | 1.4 J @ 1064 nm<br>0.5 J @ 532 nm<br>0.2 J @ 785 nm | 1.4 J @ 1064 nm<br>0.5 J @ 532 nm<br>0.2 J @ 785 nm<br>2.0 J @ RTP mode(1064 nm)5)<br>3.0 J @ FR mode(1064 nm)5) |
| Spot size (mm) | - Zoom Collimator (1064, 532 nm) | - Zoom Collimator (1064, 532 nm) |
| | 1~10 mm | 5~10 mm |
| | - Zoom (1064, 532 nm) | - Zoom (1064, 532 nm) |
| | 1~7 mm | 1~7 mm |
| | - 1064 FX | - 1064 FX |
| | 5 mm x 5 mm | 5 mm x 5 mm |
| | - 532 FX | - 532 FX |
| | 4 mm x 4 mm | 4 mm x 4 mm |
| | - DIA FX 785 (785 nm) | - DIA FX 785 (785 nm) |
| | 8 mm x 8 mm | 8 mm x 8 mm |
| | - DIA FX 785 (785 nm) | - DIA FX 785 (785 nm) |
| | 5 mm x 5 mm | 5 mm x 5 mm |
| | - 785 Zoom (785 nm) | - 785 Zoom (785 nm) |
| | 1 mm x 1 mm ~ 7 mm x 7 mm | 1 mm x 1 mm ~ 7 mm x 7 mm |
| | - 785 Colimator (785 nm) | - 785 Colimator (785 nm) |
| | 7 mm x 7 mm | 7 mm x 7 mm |
| Repetition Rate (Hz) | 1-10 @ 1064 nm<br>1-10 @ 532 nm<br>1-10 @ 785 nm | 1-10 @ 1064 nm<br>1-10 @ 532 nm<br>1-10 @ 785 nm |
| Laser Type | Q-switched Nd:YAG and<br>Ti:sapphire | Q-switched Nd:YAG and<br>Ti:sapphire |
| Activation | Via foot-switch | Via foot-switch |
| Display | TFT LCD Touch screen | TFT LCD Touch screen |
| Electrical Power | 220-230 V~, 50/60 Hz | 220-230 V~, 50/60 Hz |
| Beam Delivery System | Articulated Arm with Handpiece | Articulated Arm with Handpiece |
| System Dimensions (mm) | 936(H) x298(W) x 819(D) | 936(H) x298(W) x 819(D) |
| System Weight (kg) | 80 | 80 |

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510(k) Summary

Table 2 Comparison of the proposed device to the secondary predicate device.

| | Predicate Device(2) | Proposed Device |
|--------------------------------|---------------------|---------------------|
| 510(K) Number | K202288 | K243780 |
| Product Code | GEX | GEX |
| Classification /<br>Regulation | Class II/878.4810 | Class II/878.4810 |
| Manufacturer | SNJ Co., Ltd. | Laseroptek Co.,Ltd. |
| Device Name | Finebeam | HELIOS 785 Pico |

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| Model No. | - | 1754V2…