Who is the manufacturer of HELIOS IV 785?

Laseroptek Co., Ltd. filed the 510(k) submission for HELIOS IV 785 (K212663).

What is the FDA product code for HELIOS IV 785?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for HELIOS IV 785?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HELIOS IV 785?

Helios III Q-Switched Nd: Y AG Laser System (K152856); PicoWay Laser System (K170597).

Who can help prepare an FDA 510(k) submission like HELIOS IV 785?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HELIOS IV 785

K212663 · Laseroptek Co., Ltd. · GEX · Jun 9, 2022 · General, Plastic Surgery

Device Facts

Record ID	K212663
Device Name	HELIOS IV 785
Applicant	Laseroptek Co., Ltd.
Product Code	GEX · General, Plastic Surgery
Decision Date	Jun 9, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

[Indication for use of Q-switched Nd:YAG Laser] - Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm) - Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) - Tattoo Removal (1064nm, 532nm) - dark ink : blue and black (1064nm) - light ink : red, sky blue, green (532nm) - Treatment of Vascular Lesions (532nm) - port wine birthmarks - telangiectaias - spider angioma - cherry angioma - spider nevi - Treatment of Pigmented Lesions (1064nm, 532nm) - café-au-lait birthmarks (532nm) - solar lentiginos (532nm) - senile lentiginos (532nm) - becker's nevi (532nm) - freckles (532nm) - nevus spilus (532nm) - nevus of ota (1064nm) [Indication 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) * O-switched Nd: Y AG Laser and Ti:Sapphire Laser cannot be used simultaneously *

Device Story

HELIOS IV 785 is a multi-wavelength laser system (Q-switched Nd:YAG 1064nm/532nm and Ti:Sapphire 785nm) for dermatological applications. Device inputs include user-selected parameters via color touch screen; system delivers thermal energy to epidermis/dermis via articulated arm and handpiece. Operated by clinicians in a clinic setting. Output is pulsed laser light for tissue interaction. System includes foot switch for activation. Q-switched Nd:YAG and Ti:Sapphire lasers cannot be used simultaneously. Benefits include precise tissue ablation, tattoo pigment clearance, and treatment of vascular/pigmented lesions.

Clinical Evidence

Bench testing only. Performance evaluated against IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-2-22 (laser safety), IEC 60825-1 (laser product safety), ISO 14971 (risk management), and ISO 10993-5/10 (biocompatibility). No clinical data provided.

Technological Characteristics

Multi-wavelength laser system (1064nm, 532nm, 785nm). Q-switched Nd:YAG and Ti:Sapphire sources. Articulated arm beam delivery. TFT LCD touch screen interface. Electrical: 220-230 VAC, 50/60Hz. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 14971, ISO 10993. Dimensions: 936x298x819mm; Weight: 80kg.

Indications for Use

Indicated for incision, excision, ablation, and vaporization of soft tissue; removal/lightening of unwanted hair; tattoo removal (various colors); treatment of vascular lesions (e.g., port wine birthmarks, telangiectasias, angiomas); and treatment of pigmented lesions (e.g., birthmarks, lentigines, nevi). Ti:Sapphire laser (785nm) indicated for tattoo removal (green/blue) in Fitzpatrick skin types II-IV.

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 III Q-Switched Nd: Y AG Laser System (K152856)
PicoWay Laser System (K170597)

Related Devices

K230373 — HELIOS 785 Pico · Laseroptek Co., Ltd. · May 22, 2023
K243780 — HELIOS 785 Pico (1754V2) · Laseroptek Co., Ltd. · Feb 7, 2025
K172908 — Q-Switched Nd:YAG Laser System · Ami, Inc. · Dec 7, 2017
K193609 — Q Switched Nd: YAG Laser machine · Beijing Lead Beauty S & T Co., Ltd. · Mar 20, 2020
K083203 — HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM · Laseroptek Co., Ltd. · Apr 28, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 9, 2022 Laseroptek Co., Ltd. % Do-Hyun Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul. Seoul 06210 Korea, South Re: K212663 Trade/Device Name: Helios Iv 785 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: May 4, 2022 Received: May 5, 2022 Dear Do Kim: 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Purva Pandya 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 510(k) Number (if known) K212663 Device Name HELIOS IV 785 #### Indications for Use (Describe) [Indication for use of Q-switched Nd:YAG Laser] - Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm) - Removal or lightening of unwanted hair with or without adjuvant preparation (1064mm) - Tattoo Removal (1064nm, 532nm) - dark ink : blue and black (1064nm) - · light ink : red, sky blue, green (532nm) - Treatment of Vascular Lesions (532nm) - · port wine birthmarks - · telangiectaias - · spider angioma - · cherry angioma - · spider nevi - Treatment of Pigmented Lesions (1064nm, 532nm) - · café-au-lait birthmarks (532nm) - · solar lentiginos (532nm) - · senile lentiginos (532nm) - · becker's nevi (532nm) - · freckles (532nm) - · nevus spilus (532nm) - nevus of ota (1064nm) - [Indication 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) - * O-switched Nd: Y AG Laser and Ti:Sapphire Laser cannot be used simultaneously * Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | 510(k) Summary | |----------------| | K212663 | ## 5. 510(k) Summary - K212663 ## 1. General Information | Applicant/Submitter: | Laseroptek Co., Ltd. | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | #114, #116, #117, #203, #204 Hyundai I Valley 31 Galmachi-Ro, 244beon-gil, Jungwon-Gu Seongnam-Si, Gyeonggi-do, 13212 Rep. of Korea (South Korea) Tel) +82.31.8023.5150 Fax) +82.31.8023.5151 | | Contact Person: | Do-Hyun Kim, BT Solutions, Inc. | | Address: | 904, Eonju-ro 86-gil 5, Gangnam-gu, Seoul, 06210, Republic of Korea Tel) +82.2.538.9140 Email) ceo@btsolutions.co.kr | | Preparation Date: | June 7, 2022 | ## 2. Device Name and Code | Device Trade Name: | HELIOS IV 785 | |----------------------|----------------------------------------------------------------------------------------| | Common Name: | Q-switched Nd:YAG and Gain switched Ti:sapphire Laser System | | Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology | | Product Code: | GEX | | Regulation Number: | 878.4810 | | Classification: | Class II | | Review Panel: | General & Plastic Surgery | {4}------------------------------------------------ #### 3. Predicate Device HELIOS IV 785 is substantially equivalent to the following devices: | 1 HUIV VII 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------|--|--| | Applicant | Device Name | , 510(k) Number | | | | Laseroptek Co., Ltd. | Helios III Q-Switched Nd: Y AG Laser | K152856 | | | | | System | | | | | Syneron Candela | PicoWay Laser System | K170597 | | | | Corporation | | | | | Table 5 1 Predicate device #### 4. Device Description HELIOS IV 785 consist of a set of Q-switched Nd: YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm), and controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch. #### 5. Indications / Intended Use [Indication for use of O-switched Nd:YAG Laser] - Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064mm) - Removal or lightening of unwanted hair with or without adjuvant preparation (1064mm) - Tattoo Removal (1064nm, 532nm) - dark ink : blue and black (1064nm) - light ink : red, sky blue, green (532nm) - Treatment of Vascular Lesions (532nm) - port wine birthmarks - telangiectaias ● - spider angioma - cherry angioma - spider nevi - Treatment of Pigmented Lesions (1064nm, 532nm) - café-au-lait birthmarks (532nm) - solar lentiginos (532nm) - senile lentiginos (532nm) - becker's nevi (532nm) {5}------------------------------------------------ #### 510(k) Summary K212663 - freckles (532nm) - nevus spilus (532nm) - nevus of ota (1064nm) [Indication 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 .* ## 6. Technical Characteristics in Comparison HELIOS IV 785 is substantially equivalent to the following legally marketed predicate devices. Two predicates were cited to support substantial equivalence for the proposed indications for use. ## 6.1. Technical Characteristics in Comparison with the Predicate device (1) HELIOS IV 785 is substantially equivalent to the predicate device (K152856) for O-switched Nd:YAG (1064 nm) laser and frequency doubled KTP Nd:YAG (532 nm) laser. | | Predicate Device (1) | Proposed Device | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | 510(K) Number | K152856 | K212663 | | Product Code | GEX | GEX | | Classification / Regulation | Class II/878.4810 | Class II/878.4810 | | Manufacturer | Laseroptek Co.,Ltd. | Laseroptek Co.,Ltd. | | Device Name | Helios III | HELIOS IV 785 | | Clearance Date | July 17, 2015 | N/A | | Intended Use / Indications for Use: | The Helios III Q-Switched Nd:YAG Laser System delivers pulse wave laser light in the contact or noncontact mode for; | [Indication for use of Q-switched Nd:YAG Laser] | | | - Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) | - Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm) | | | - Removal or lightening of unwanted hair with or without adjuvant preparation (1064 nm) | - Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) | | | Table 5.2 Comparison table between Predicate device (1) and Proposed device | | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K212663 | | | | - Tattoo Removal (1064nm, 532nm) • dark ink: blue and black (1064nm) • light ink: red, sky blue, green (532nm) - Treatment of Vascular Lesions: (532nm) • port wine birthmarks • telangiectasias • spider angioma • cherry angioma • spider nevi - Treatment of Pigmented Lesions: (1064nm,532nm) • café-au-lait birthmarks (532nm) • solar lentiginos (532nm) • senile lentiginos (532nm) • becker's nevi (532nm) • freckles (532nm) • nevus spilus (532nm ) • nevus of ota (1064nm) | - Tattoo Removal (1064nm, 532nm) • dark ink : blue and black (1064nm) • light ink : red, sky blue, green (532nm) - Treatment of Vascular Lesions (532nm) • port wine birthmarks • telangiectasias • spider angioma • cherry angioma • spider nevi - Treatment of Pigmented Lesions (1064nm, 532nm) • café-au-lait birthmarks (532nm) • solar lentiginos (532nm) • senile lentiginos (532nm) • becker's nevi (532nm) • freckles (532nm) • nevus spilus (532nm) • nevus of ota (1064nm) [Indication 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.* | | | | | | Wavelength | 1064,532 nm (Accuracy ±20%) | 1064,532, 785mm (Accuracy ±20%) | | Pulse Duration (max) | 10 ns | 10 ns | | Pulse Energy (max) | 1.3 J (0.5J @ 532 nm) / pulse | 1.4 J (0.5J @ 532 nm) / pulse | | Fluence | 1 – 8 J/cm2 @1 to 8mm spot size | 1 – 8 J/cm2 @1 to 10mm spot size | | Peak Power (Gigawatts) | 0.260 (1064nm) 0.100 (532nm) | 0.280 (1064nm) 0.100 (532nm) | | Spot size (mm) | Up to 8 mm | Up to 10 mm | | Repetition Rate | Single Shot, 1~10 Hz | Single, 1~10Hz (Accuracy: ± 20%) (1064nm, 532nm) | | Laser Type | Q-switched Nd:YAG | Q-switched Nd:YAG and Ti:sapphire | | Activation | Via foot-switch | Via foot-switch | | Display | TFT LCD Touch screen | TFT LCD Touch screen | | Electrical Power | AC 230 V, 50/60 Hz | 220-230 VAC, 50/60Hz | | Beam Delivery System | Articulated Arm with Handpiece | Articulated Arm with Handpiece | {6}------------------------------------------------ # 510(k) Summary {7}------------------------------------------------ # 510(k) Summary | K212663 | | | |-----------------------|--------------------------|--------------------------| | System Dimensions(mm) | 935(H) X 297(W) X 818(D) | 936(H) X 298(W) X 819(D) | | System Weight (kg) | 80 | 80 | #### 6.2. Technical Characteristics in Comparison with the Predicate device (2) HELIOS IV 785 is substantially equivalent to the predicate device (K170597) for the Ti:sapphire laser(785nm). | | Predicate Device (2) | Proposed Device | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) Number | K170597 | K212663 | | Product Code | GEX | GEX | | Classification / Regulation | Class II/878.4810 | Class II/878.4810 | | Manufacturer | Syneron Candela Corporation | Laseroptek Co.,Ltd. | | Device Name | PicoWay Laser System | HELIOS IV 785 | | Clearance Date | 25 May 2017 | N/A | | Intended Use / Indications for Use: | The PicoWay laser system is indicated for the following at the specified wavelength: 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The Resolve handpieces are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. | [Indication for use of Q-switched Nd:YAG Laser] - Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm) - Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) - Tattoo Removal (1064nm, 532nm) dark ink : blue and black (1064nm) light ink : red, sky blue, green (532nm) - Treatment of Vascular Lesions (532nm) • port wine birthmarks • telangiectasias • spider angioma • cherry angioma • spider nevi - Treatment of Pigmented Lesions (1064nm, 532nm) • café-au-lait birthmarks (532nm) • solar lentiginos (532nm) • senile lentiginos (532nm) • becker's nevi (532nm) • freckles (532nm) • nevus spilus (532nm) • nevus of ota (1064nm) [Indication for use of Ti:Sapphire Laser] | #### Table 5.3 Comparison table between Predicate device (2) and Proposed device {8}------------------------------------------------ | | HELIOS IV 785 | | |--------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 510(k) Summary | | | | K212663 | | | | | - 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.* | | Wavelength | 1064nm, 532nm, 785 nm | 1064mm,532 nm, 785mm (Accuracy ±20%) | | Pulse Duration (max) | 240 - 750 (ps) | 600ps | | Pulse Energy (max) | 450mJ (1064nm) 220mJ (532nm) 120mJ (785nm) | 200mJ (785nm) | | Fluence | 0.16 - 4.0 J/cm2 | Spot size 1mm : 4.0J/cm2 Spot size 2mm : 4.0J/cm2 Spot size 3mm : 2.8J/cm2 Spot size 4mm : 1.5J/cm2 Spot size 5mm : 1.0J/cm2 Spot size 6mm : 0.7J/cm2 Spot size 7mm : 0.5J/cm2 Spot size 8mm : 0.3J/cm2 | | Peak Power (Gigawatts) | 0.9 (1064nm) 0.6 (532nm) 0.4 (785nm) | 0.33 (785nm) | | Spot size (mm) | up to 10 mm | Up to 8mm | | Repetition Rate (Hz) | Single, 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm) | Single, 1~5Hz (Accuracy: ± 20%) (785nm) | | Laser Type | Q-switched Nd:YAG and Ti:sapphire | Q-switched Nd:YAG and Ti:sapphire | | Activation | Via foot-switch | Via foot-switch | | Display | LCD Touch screen | TFT LCD Touch screen | | Electrical Power | 200-240 VAC, 50/60 Hz, 30 A, 4600 VA single | 220-230VAC, 50/60Hz | | Beam Delivery System | Articulated Arm with Handpiece | Articulated Arm with Handpiece | | System Dimensions(mm) | 1070 (H) x 460 (W) x 690 (D) | 936(H) x298(W) x 819(D) | | System Weight (kg) | 125 | 80 | #### 7. Performance Data Non-clinical tests: Testing conducted on the HELIOS IV 785 shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.10 and 1040.11. Other performance, such as electromagnetic compliance, etc, were tested using following standards: - HELIOS IV 785 is tested and evaluated according to IEC 60601-1:2005+A1 2012. All the results presented in the submission demonstrate general requirements for basic safety and essential performance. - Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2:2014. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances. {9}------------------------------------------------ #### 510(k) Summary K212663 - -HELIOS IV 785 is tested and evaluated according to FDA-recognized consensus standard IEC 60601-1-6:2010+AMD1:2013. All the results presented here demonstrated the General requirements for safety - Collateral Standard: Usability. - HELIOS IV 785 is tested and evaluated according to FDA-recognized consensus standard -IEC 60601-2-22:2019. All the results presented here demonstrated the particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. - -Safety of laser products is evaluated according to IEC 60825-1:2014. All the results presented here demonstrated the equipment classification and requirements. - -Risk management was recorded according to the FDA-recognized consensus standard ISO 14971:2012. All the results presented here demonstrated the application of risk management to medical devices. - -Usability was documented according to the FDA-recognized consensus standard IEC 62366:2008. All the results presented here demonstrated the application of usability engineering to medical devices. - -Biocompatibility was tested and evaluated according to FDA-recognized consensus standard ISO 10993-5:2009and ISO 10993-10:2013. #### 8. Substantial Equivalence The HELIOS IV 785, subject of this submission, is a modification of the Helios III Q-Switched Nd: YAG Laser System cleared under K152856. The modification is about adding the Ti:Sapphire laser (785 nm) in the previous Q-switched Nd: Y AG laser system. Based upon the predicted overall performance characteristics for the HELIOS IV 785, Laseroptek Co. Ltd. believes that no significant differences exist in usage of its underlying technological principles between HELIOS IV 785 and the predicate devices. #### 9. Conclusions The technological characteristics of the subject device HELIOS IV 785 are comparable to the predicate devices for indications for use. Thus, subject device HELIOS IV 785 is concluded to be substantially equivalent to the predicate devices.