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 Benign Vascular Lesions (532nm)
port wine birthmarks
telangiectaias
spider angioma
cherry angioma
spider nevi
Treatment of Benign 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.

Device Description

HELIOS 785 Pico consists of a Q-switched Nd:YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm). The device consists of a main body, color touch screen, articulated arm, foot switch and several handpieces, and is controlled by an embedded processor. The device uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis to achieve its intended purpose. It is for prescription use only.

AI/ML Overview

The provided text is a 510(k) Premarket Notification submission for the HELIOS 785 Pico laser device. This document focuses on demonstrating substantial equivalence to existing predicate devices based on technical specifications and non-clinical testing, rather than presenting clinical study data to prove performance against specific acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, the information requested in points 1-9 cannot be fully extracted or inferred from this document. This device is a laser surgical instrument, not an AI/SaMD, and its clearance pathway typically does not involve extensive clinical studies with human readers, ground truth consensus, or the specific types of performance metrics associated with AI algorithms.

Here's a breakdown of why the information is not present and what can be extracted:

Information Not Present in the Document:

1. Table of acceptance criteria and reported device performance (in the context of AI/SaMD): This document details technical specifications and non-clinical test validations (e.g., electrical safety, EMC, laser safety standards). It does not present acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, or other measures typically used for AI/SaMD.
2. Sample size and data provenance for a test set: Not applicable as there's no clinical test set for AI performance. Non-clinical tests were conducted on the device itself.
3. Number of experts and qualifications for ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study or effect size for human reader improvement with AI assistance was performed or reported.
6. Standalone performance for an algorithm: Not applicable, as this is a hardware laser device, not a standalone algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as there is no AI algorithm being trained.
9. How ground truth for the training set was established: Not applicable.

What can be extracted or inferred from the document:

Device Type: Laser Surgical Instrument (specifically, a combination of Q-switched Nd:YAG and Ti:Sapphire lasers).
Regulatory Class: Class II (Product Code: GEX).
Indications for Use: Detailed for both Q-switched Nd:YAG Laser (incision, excision, ablation, vaporization of soft tissue; hair removal; tattoo removal of various colors; treatment of benign vascular lesions; treatment of benign pigmented lesions) and Ti:Sapphire Laser (removal of green and blue tattoos for Fitzpatrick skin types II-IV).
Comparison to Predicate Devices: The submission is based on demonstrating substantial equivalence to the HELIOS IV 785 (K212663) as the primary predicate and PicoWay Laser System (K191685) as a reference predicate.
Non-Clinical Testing: The document lists various non-clinical tests conducted to verify the device conforms to relevant mandatory performance standards and design specifications. These include:
- IEC 60601-1:2005/A1:2012 (Medical Electrical Equipment General Requirements)
- IEC 60601-1-2:2014 (Electromagnetic Compatibility)
- IEC 60601-2-22:2012 (Specific Requirements for Laser Equipment)
- IEC 60825-1: 2014 (Safety of laser products - Part 1: Equipment classification and requirements)
- Biocompatibility evaluation per ISO 10993 and FDA guidance
- Usability per IEC 60601-1-6 and IEC 62366
- Risk management per ISO 14971
- Software Validation & Verification Test
- Bench Testing to verify the performance.
No Clinical Study: The document explicitly states, "No clinical study is included in this submission." This indicates that the substantial equivalence determination for this device relies primarily on the demonstrated technical equivalence and non-clinical testing results, rather than clinical efficacy studies.

In summary, the provided document is a regulatory submission for a physical medical device (laser), not an AI/SaMD. Therefore, it does not contain the information typically associated with the acceptance criteria and study designs for proving AI device performance.

Summary

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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

May 22, 2023

Laseroptek Co., Ltd. % Wonmi Lee Manager BT Solutions. Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul. Seoul 06210 Korea, South

Re: K230373

Trade/Device Name: HELIOS 785 Pico 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: April 21, 2023 Received: April 21, 2023

Dear Wonmi Lee:

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.

Jianting Wang -S

Jianting Wang 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

510(k) Number (if known) K230373

Indications for Use (Describe)

[Indication for use of Q-switched Nd:YAG Laser]

Device Name HELIOS 785 Pico

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 Benign Vascular Lesions (532nm)

port wine birthmarks

telangiectaias

spider angioma

cherry angioma

spider nevi

Treatment of Benign 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.

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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CONTINUE ON A SEPARATE PAGE IF NEEDED.

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HELIOS 785 Pico 510(k) Summary 510(k) Summary 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: Wonmi Lee, BT Solutions, Inc. Address: 904, Eonju-ro 86-gil 5, Gangnam-gu, Seoul, 06210 Republic of Korea (South Korea) Tel: +82.2.538.9140 Email: wmlee@btsolutions.co.kr May 16, 2023 Preparation Date:

2. Identification of the Proposed Device

Trade/Device Name:	HELIOS 785 Pico
Common Name:	Q-switched Nd:YAG and Gain switched Ti:sapphire LaserSystem
Classification Name:	Powered Laser Surgical Instrument
Regulation Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology
Regulation Number:	21 CFR 878.4810
Regulatory Class:	Class II
Product Code:	GEX

3. Identification of the Predicate Device

Predicate Type	510(k) Number	Device Name	Applicant
Primary Predicate	K212663	HELIOS IV 785	Laseroptek Co., Ltd.
Reference Predicate	K191685	PicoWay LaserSystem	Syneron CandelaCorporation

4. Device Description

5. Indications / Intended Use

[Indication for use of Q-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)

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HELIOS 785 Pico

510(k) Summary

Tattoo Removal (1064nm, 532nm)
dark ink : blue and black (1064nm) ●
. light ink : red, sky blue, green (532nm)
Treatment of Benign Vascular Lesions (532nm)
port wine birthmarks ●
telangiectaias
. spider angioma
. cherry angioma
spider nevi ●
Treatment of Benign 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. (785mm)

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

6. Substantial Equivalence Comparison

Comparison of the Indications for Use: Indications for use statement of the subject and primary predicate devices are comparable.

	Predicate Device	Subject Device
510(K) Number	K212663	K230373
Wavelength (nm)	1064532	1064532
(Accuracy ±20%)	785	785
Pulse Duration (max)	5-10 ns @ 1064 nm5-10 ns @ 532 nm600 ps @ 785 nm	5-10 ns @ 1064 nm5-10 ns @ 532 nm600 ps @ 785 nm
Pulse Energy (max)	1.4 J @ 1064 nm0.5 J @ 532 nm0.2 J @ 785 nm	1.4 J @ 1064 nm0.5 J @ 532 nm0.2 J @ 785 nm
Fluence (J/cm², max)*	8 @ 1064nm8 @ 532 nm4 @ 785 nm	8 @ 1064nm8 @ 532 nm4 @ 785 nm
Peak Power (GW)	0.28 @ 1064 nm0.1 @ 1064 nm0.33 @ 785 nm	0.28 @ 1064 nm0.1 @ 1064 nm0.33 @ 785 nm

Comparison of Technology:

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510(k) Summary
Max. Average Power (W)	14 @ 1064 nm5 @ 1064 nm2 @ 785 nm	14 @ 1064 nm5 @ 1064 nm2 @ 785 nm
Spot Size (mm)	1-10 @ 1064 nm1-10 @ 532 nm1-8 @ 785 nm	1-10 @ 1064 nm1-10 @ 532 nm1-8 @ 785 nm
Repetition Rate (Hz)	1-10 @ 1064 nm1-10 @ 532 nm1-5 @ 785 nm	1-10 @ 1064 nm1-10 @ 532 nm1-10 @ 785 nm
Display	TFT LCD Touch screen	TFT LCD Touch screen
Electrical Power	220-230VAC, 50/60Hz	220-230VAC, 50/60Hz
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

HELIOS 785 Pico

*Maximum fluence is not available for all spot sizes.

All but one (i.e., repetition rate) technological features of the subject device are comparable to the corresponding technological features of the predicate device. Additional information is provided (i.e., technological characteristics of the reference predicate) to support the argument that doubling the repetition rate for the 785 nm laser is not expected to adversely affect the device performance or patient safety for the proposed intended use.

7. Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device conforms to the relevant mandatory performance standards for laser products 21 CFR 1040.11, met all design specifications, and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:

IEC 60601-1:2005/A1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic . Safety and Essential Performance
. IEC 60601-1-2:2014 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility
IEC 60601-2-22:2012, Medical Electrical Equipment Part 2-22: Particular Requirements for Basic Safety ● and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment
. IEC 60825-1: 2014, Safety of laser products - Part 1: Equipment classification and requirements
Biocompatibility evaluation per ISO 10993 and FDA guidance ●
Usability per IEC 60601-1-6 and IEC 62366 ●
Risk management per ISO 14971 ●
Software Validation & Verification Test ●
. Bench Testing to verify the performance.

8. Clinical Testing

No clinical study is included in this submission.

9. Substantial Equivalence

Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.

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.