(290 days)
Not Found
No
The summary describes a laser system controlled by an embedded processor, but there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on electrical, laser safety, and usability standards, not AI/ML performance metrics.
Yes
The "Summary of Performance Studies" explicitly states that the device was evaluated according to "IEC 60601-2-22:2019" which covers "particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment," directly classifying it as a therapeutic device.
No
The device description and indications for use specify that the laser system is used for various dermatological treatments and procedures (e.g., incision, excision, hair removal, tattoo removal, treatment of vascular/pigmented lesions), which are therapeutic in nature, not diagnostic.
No
The device description explicitly states it consists of a set of lasers, an embedded processor, focusing optics, a main body, color touch screen, articulated arm, hand piece, and foot switch, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to treating conditions on the skin (incision, excision, ablation, hair removal, tattoo removal, treatment of vascular and pigmented lesions). IVDs are used to diagnose diseases or conditions by examining samples taken from the body (like blood, urine, tissue).
- Device Description: The device description clearly states it's a laser system used in dermatology that delivers thermal energy to the skin. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is a therapeutic laser system used for various dermatological procedures.
N/A
Intended Use / Indications for 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 (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)
- Q-switched Nd: Y AG Laser and Ti:Sapphire Laser cannot be used simultaneously *
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue for general dermatology
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
- O-switched Nd: Y AG Laser and Ti:Sapphire Laser cannot be used simultaneously *
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| 510(k) Summary |
|---|
| K212663 |
5. 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: | 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, 110 Hz | Single, 110Hz (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.