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 *

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.

AI/ML Overview

This is a 510(k) premarket notification for the Laseroptek Co., Ltd. HELIOS IV 785, a laser surgical instrument for use in general and plastic surgery and in dermatology. The document focuses on demonstrating substantial equivalence to predicate devices, rather than an AI-powered device. Therefore, the typical acceptance criteria and study design elements for AI/ML device performance are not applicable or described in this document.

The document does not describe the acceptance criteria and a study that proves a device meets them in the context of an AI/ML algorithm. Instead, it is a Premarket Notification (510(k)) for a medical device (a laser system), demonstrating substantial equivalence to already legally marketed predicate devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance for an AI device is not present in this document. The document focuses on the technical characteristics and intended use of the laser system.

Here's what can be extracted and what cannot:

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

Not applicable in the context of AI/ML performance. This document describes a laser system. The "performance data" section refers to compliance with safety standards and electrical/mechanical performance, not diagnostic accuracy or AI model performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. There is no mention of a test set, data (images/signals), or data provenance in the context of an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no discussion of ground truth establishment by experts for an AI/ML output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set or adjudication method is described for an AI/ML algorithm.

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

Not applicable. This is a hardware device (laser system), not an AI/ML diagnostic or assistive device. No MRMC study is mentioned.

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

Not applicable. This is a laser system, not an algorithm.

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

Not applicable. There is no AI/ML component discussed that would require ground truth.

8. The sample size for the training set:

Not applicable. No AI/ML training set is mentioned.

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

Not applicable. No AI/ML training set or ground truth process is mentioned.

Summary of what the document does describe (relevant to device performance, but not AI performance):

The document details the technical characteristics of the HELIOS IV 785 laser system and compares them to two predicate devices (Helios III Q-Switched Nd:YAG Laser System and PicoWay Laser System) to demonstrate substantial equivalence.

Performance Data (Non-clinical tests mentioned):

The device underwent non-clinical testing to ensure compliance with various standards related to laser products, general safety, electromagnetic compatibility, usability, and biocompatibility.

21 CFR 1040.10 and 1040.11 (mandatory performance standards for laser products)
IEC 60601-1:2005+A1:2012 (general requirements for basic safety and essential performance)
IEC 60601-1-2:2014 (electromagnetic disturbances)
IEC 60601-1-6:2010+AMD1:2013 (usability)
IEC 60601-2-22:2019 (particular requirements for surgical, cosmetic, therapeutic and diagnostic laser equipment)
IEC 60825-1:2014 (safety of laser products, classification and requirements)
ISO 14971:2012 (risk management)
IEC 62366:2008 (usability engineering)
ISO 10993-5:2009 and ISO 10993-10:2013 (biocompatibility)

The "reported device performance" in this context is the successful evaluation and compliance with these non-clinical standards, which are considered sufficient to establish substantial equivalence for the safety and effectiveness of the laser device.

Summary

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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.

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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 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

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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)

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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 31Galmachi-Ro, 244beon-gil, Jungwon-GuSeongnam-Si, Gyeonggi-do, 13212Rep. of Korea (South Korea)Tel) +82.31.8023.5150Fax) +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 KoreaTel) +82.2.538.9140Email) 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 switchedTi:sapphire Laser System
Classification Name:	Laser surgical instrument for use in general andplastic surgery and in dermatology
Product Code:	GEX
Regulation Number:	878.4810
Classification:	Class II
Review Panel:	General & Plastic Surgery

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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

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)

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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 forUse:	The Helios III Q-Switched Nd:YAG LaserSystem delivers pulse wave laser light in thecontact or noncontact mode for;	[Indication for use of Q-switched Nd:YAGLaser]
	- Incision, excision, ablation, vaporization ofsoft tissue for general dermatology (1064 nm)	- Incision, excision, ablation, vaporization ofsoft tissue for general dermatology(1064nm)
	- Removal or lightening of unwanted hairwith or without adjuvant preparation (1064 nm)	- Removal or lightening of unwanted hairwith 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 skintypes II-IV to treat the following tattoocolors: green and blue. (785nm)Q-switched Nd:YAG Laser andTi:Sapphire Laser cannot be usedsimultaneously.

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 DeliverySystem	Articulated Arm with Handpiece	Articulated Arm with Handpiece

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510(k) Summary

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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 forUse:	The PicoWay laser system is indicated forthe following at the specified wavelength:532nm: Removal of tattoos for Fitzpatrickskin types I-III to treat the following tattoocolors: red, yellow and orange.785nm: Removal of tattoos forFitzpatrick skin types II-IV to treat thefollowing tattoo colors: green and blue.1064nm: Removal of tattoos for all skintypes (Fitzpatrick I-VI) to treat thefollowing tattoo colors: black, brown,green, blue and purple.The PicoWay laser system is also indicatedfor benign pigmented lesions removal forFitzpatrick Skin Types I-IV.The Resolve handpiece (1064 nm) is alsoindicated for the treatment of acne scars inFitzpatrick Skin Types II-V.The Resolve handpieces are also indicatedfor treatment of wrinkles in Fitzpatrick SkinTypes I-IV.	[Indication for use of Q-switched Nd:YAGLaser]- Incision, excision, ablation, vaporizationof soft tissue for general dermatology(1064nm)- Removal or lightening of unwanted hairwith 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

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	HELIOS IV 785
	510(k) Summary
	K212663
		- Removal of tattoos for Fitzpatrick skintypes II-IV to treat the following tattoocolors: green and blue. (785nm)
		Q-switched Nd:YAG Laser andTi:Sapphire Laser cannot be usedsimultaneously.
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/cm2Spot size 2mm : 4.0J/cm2Spot size 3mm : 2.8J/cm2Spot size 4mm : 1.5J/cm2Spot size 5mm : 1.0J/cm2Spot size 6mm : 0.7J/cm2Spot size 7mm : 0.5J/cm2Spot 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 VAsingle	220-230VAC, 50/60Hz
Beam Delivery System	Articulated Arm with Handpiece	Articulated Arm with Handpiece
SystemDimensions(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.

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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.

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.