(60 days)
[Indications for use of Q-switched Nd:YAG Laser]
1064 nm (including RTP 1064 mode):
- Incision, excision, ablation, vaporization of soft tissue for general dermatology
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Treatment melasma
- Treatment of Pigmented Lesions
- · nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
- dark ink: black, blue and brown
532 nm:
- Treatment of Vascular Lesions
- · port wine birthmarks
- · telangiectaias
- · spider angioma
- · cherry angioma
- · spider nevi
- Treatment of Pigmented Lesions
- · café-au-lait birthmarks
- · solar lentiginos
- · senile lentiginos
- · becker's nevi
- · freckles
- nevus spilus
- nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
- · light ink: red, sky blue, green, tan, purple, and orange
[Indications for use of FR mode in Nd:YAG Laser]
- Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofollicultis Barbae). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins
- Coagulation and hemostasis of soft tissue
- Treatment of wrinkles
[Indications for use of Ti:Sapphire Laser]
785nm: - Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
*Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously *
The flash lamp as a laser pumping source converts electric energy to light energy when a high voltage is applied. Nd:YAG crystal with the specific resonator emits an 1064nm single wavelength laser by absorbing light energy from the flash lamp. Q-switching mode is applied to the 1064nm laser resonator to amplify the 1064nm laser with about 10ns short pulse width.
The amplified O-switched 1064nm laser is secondarily amplified by an another Nd: YAG crystal and, then is converted to a second harmonic 532nm laser by passing through KTP crystal.
Finally a 785nm laser is emitted by the 785nm cavity with Ti:Sapphire crystal using the 532nm laser as a laser pumping source.
HELIOS 785 Pico Laser System can emit 1064nm, 532nm, and 785nm laser selectively by switching the wavelength conversion optical modules. The 1064nm laser is emitted by only Nd: Y AG crystal resonator and the 532nm laser can be emitted with the 1064nm laser and KTP crystal. The 785nm laser can be emitted by all optical modules.
The Q-switch mode normally produces polarized light, but it is also possible to set the FR(Free Running) mode, which emits light in all directions by removing the optics of the Q-switch module. Additionally, the RTP(Real Twin Pulse) mode can be set to generate two identical pulses with a very short interval instead of a single pulse.
The HELIOS 785 Pico laser system consists of:
a) A high voltage power supply, which converts and rectifies Alternating Current (AC) to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.
c) The micro processor based controller unit, which regulates the functions of both lasers and allows parameter selection by the user.
d) The Nd: YAG laser + Ti:sapphire laser head.
This document is a 510(k) summary for the HELIOS 785 Pico (1754V2) laser system. It describes the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain explicit acceptance criteria, performance data from a specific study to prove the device meets acceptance criteria, or details regarding ground truth establishment, expert adjudication, or sample sizes for training and test sets in the context of an AI/algorithm performance study.
The "Performance Data" section (page 13) refers to non-clinical tests for safety and performance according to consensus standards, but these are general engineering and safety standards for laser products, not typical performance metrics for an AI medical device like sensitivity, specificity, or accuracy derived from clinical data.
Therefore, many requested points cannot be extracted from the provided text.
Here is the information that can be extracted, with notes for the missing information:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document refers to non-clinical safety and performance tests against consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971, IEC 60601-1-6, IEC 60601-2-22) for the laser device itself, but it does not specify quantitative acceptance criteria or clinical performance metrics (like accuracy, sensitivity, specificity) for a specific medical indication, which would typically be included for an AI/algorithm-based device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document details the laser device's technical specifications and intended uses, but it does not mention a test set or data related to any clinical evaluation for performance.
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)
This information is not provided. As there's no mention of a test set or clinical performance evaluation, there's no information on experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided. The document is for a laser surgical instrument, not an AI-assisted diagnostic or treatment planning system that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a laser system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided.
9. How the ground truth for the training set was established
This information is not provided.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 7, 2025
Laseroptek Co., Ltd. % Kim Do Hyun CEO BT Solutions, Inc. Unit 303, Gonghang-daero 337, Gangseo-gu Seoul, Seoul 07590 Korea, South
Re: K243780
Trade/Device Name: HELIOS 785 Pico (1754V2) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: December 9, 2024 Received: December 9, 2024
Dear Kim Do Hyun:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
{1}------------------------------------------------
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
{2}------------------------------------------------
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,
Digitally signed by TANISHA - Digitally signed by L. HITHE -> 22:25:46 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K243780
Device Name HELIOS 785 Pico (1754V2)
Indications for Use (Describe)
[Indications for use of O-switched Nd:YAG Laser]
1064 nm (including RTP 1064 mode):
- Incision, excision, ablation, vaporization of soft tissue for general dermatology
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Treatment melasma
- Treatment of Pigmented Lesions
- · nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
- dark ink: black, blue and brown
532 nm:
- Treatment of Vascular Lesions
- · port wine birthmarks
- · telangiectaias
- · spider angioma
- · cherry angioma
- · spider nevi
- Treatment of Pigmented Lesions
- · café-au-lait birthmarks
- · solar lentiginos
- · senile lentiginos
- · becker's nevi
- · freckles
- nevus spilus
- nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
- · light ink: red, sky blue, green, tan, purple, and orange
[Indications for use of FR mode in Nd:YAG Laser]
-
Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofollicultis Barbae). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
-
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins
-
Coagulation and hemostasis of soft tissue
-
Treatment of wrinkles
-
[Indications for use of Ti:Sapphire Laser]
-
Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
785nm:
*Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously *
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K243780
1 General Information
| Applicant/Submitter: | Laseroptek Co., Ltd. |
|---|---|
| Address: | Hyundai I Valley 114,116,117,203,204, 31,Galmachi-ro 244beon-gil, Jungwon-gu,Seongnam-si, Gyeonggi-do, Republic ofKorea |
| Contact Person: | Do Hyun Kim, BT Solutions, Inc. |
| Address: | Unit 303, Gonghang-daero 337, Gangseo-guSeoul, 07590, Republic of KoreaTel: +82-2-538-9140Email: ceo@btsolutions.co.kr |
| Preparation Date: | February 4, 2025 |
2 Device Name and Code
| Device Trade Name: | HELIOS 785 Pico |
|---|---|
| Model Name: | 1754V2 |
| Common Name: | Q-switched Nd:YAG + Gain switchedTi:sapphire Laser System |
| Classification Name: | Powered laser surgical instrument |
| Product Code: | GEX |
| Regulation Number: | 878.4810 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |
3 Technical Characteristics in Comparison to Predicate Devices
The HELIOS 785 Pico, is substantially equivalent to the following legally marketed predicate devices: HELIOS 785 Pico (1754V1) (K230373) and Finebeam (K202288);
| Predicate Device (1) | Proposed Device | |
|---|---|---|
| 510(K) Number | K230373 | K243780 |
| Product Code | GEX | GEX |
| Classification /Regulation | Class II/878.4810 | Class II/878.4810 |
| Manufacturer | Laseroptek Co.,Ltd. | Laseroptek Co.,Ltd. |
Table 1 Comparison of the proposed device to the primary predicate device
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HELIOS 785 Pico(Model: 1754V2) 510(k) Summary K243780
| Device Name | HELIOS 785 Pico | HELIOS 785 Pico |
|---|---|---|
| Model No. | 1754V1 | 1754V2 |
| Intended Use /Indications forUse: | [Indication for use of Q-switchedNd:YAG Laser]- Incision, excision, ablation,vaporization of soft tissue forgeneral dermatology (1064nm)- Removal or lightening ofunwanted hair with or withoutadjuvant 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 birthmarkstelangiectaiasspider angiomacherry angiomaspider 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:SapphireLaser]- Removal of tattoos forFitzpatrick skin types II-IV totreat the following tattoo colors:green and blue. (785nm)Q-switched Nd:YAG Laser andTi:Sapphire Laser cannot be usedsimultaneously. | [Indications for use of Q-switchedNd:YAG Laser]1064 nm(including RTP 1064mode):- Incision, excision, ablation,vaporization of soft tissue forgeneral dermatology- Removal or lightening ofunwanted hair with or withoutadjuvant preparation- Treatment melasma- Treatment of Pigmented Lesionsnevus of ota- Skin resurfacing procedures forthe treatment of acne scars andwrinkles- Tattoo Removaldark ink: black, blue and brown532 nm:- Treatment of Vascular Lesionsport wine birthmarkstelangiectaiasspider angiomacherry angiomaspider nevi- Treatment of Pigmented Lesionscafé-au-lait birthmarkssolar lentiginossenile lentiginosbecker's nevifrecklesnevus spilus- Skin resurfacing procedures forthe treatment of acne scars andwrinkles- Tattoo Removallight ink: red, sky blue, green,tan, purple, and orange |
| [Indications for use of FR modein Nd:YAG Laser]- Removal of unwanted hair, forstable long term or permanenthair reduction and treatment ofPFB (Pseudofolliculitis Barbae).The laser is indicated for all skintypes, Fitzpatrick I-VI, includingtanned skin- Photocoagulation andhemostasis of pigmented andvascular lesions, such as but notlimited to port wine stains,cherry angioma, Hemangiomas,warts, telangiectasias, rosacea,leg veins, and spider veins- Coagulation and hemostasis ofsoft tissue- Treatment of wrinkles[Indications for use ofTi:Sapphire Laser]785 nm:- Removal of tattoos forFitzpatrick skin types II-IV totreat the following tattoo colors:green and blue.Q-switched Nd:YAG Laser andTi:Sapphire Laser cannot be usedsimultaneously. | ||
| Wavelength | 1064 mm, 532 mm, 785 mm | 1064 mm, 532 mm, 785 mm |
| 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 nm5-10 ns @ RTP mode(1064nm)5)300 us @ FR mode(1064 nm)5) |
| 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 nm2.0 J @ RTP mode(1064 nm)5)3.0 J @ FR mode(1064 nm)5) |
| Spot size (mm) | - Zoom Collimator (1064, 532 nm) | - Zoom Collimator (1064, 532 nm) |
| 1~10 mm | 5~10 mm | |
| - Zoom (1064, 532 nm) | - Zoom (1064, 532 nm) | |
| 1~7 mm | 1~7 mm | |
| - 1064 FX | - 1064 FX | |
| 5 mm x 5 mm | 5 mm x 5 mm | |
| - 532 FX | - 532 FX | |
| 4 mm x 4 mm | 4 mm x 4 mm | |
| - DIA FX 785 (785 nm) | - DIA FX 785 (785 nm) | |
| 8 mm x 8 mm | 8 mm x 8 mm | |
| - DIA FX 785 (785 nm) | - DIA FX 785 (785 nm) | |
| 5 mm x 5 mm | 5 mm x 5 mm | |
| - 785 Zoom (785 nm) | - 785 Zoom (785 nm) | |
| 1 mm x 1 mm ~ 7 mm x 7 mm | 1 mm x 1 mm ~ 7 mm x 7 mm | |
| - 785 Colimator (785 nm) | - 785 Colimator (785 nm) | |
| 7 mm x 7 mm | 7 mm x 7 mm | |
| Repetition Rate (Hz) | 1-10 @ 1064 nm1-10 @ 532 nm1-10 @ 785 nm | 1-10 @ 1064 nm1-10 @ 532 nm1-10 @ 785 nm |
| Laser Type | Q-switched Nd:YAG andTi:sapphire | Q-switched Nd:YAG andTi:sapphire |
| Activation | Via foot-switch | Via foot-switch |
| Display | TFT LCD Touch screen | TFT LCD Touch screen |
| Electrical Power | 220-230 V~, 50/60 Hz | 220-230 V~, 50/60 Hz |
| Beam Delivery System | Articulated Arm with Handpiece | Articulated Arm with Handpiece |
| System Dimensions (mm) | 936(H) x298(W) x 819(D) | 936(H) x298(W) x 819(D) |
| System Weight (kg) | 80 | 80 |
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510(k) Summary
Table 2 Comparison of the proposed device to the secondary predicate device.
| Predicate Device(2) | Proposed Device | |
|---|---|---|
| 510(K) Number | K202288 | K243780 |
| Product Code | GEX | GEX |
| Classification /Regulation | Class II/878.4810 | Class II/878.4810 |
| Manufacturer | SNJ Co., Ltd. | Laseroptek Co.,Ltd. |
| Device Name | Finebeam | HELIOS 785 Pico |
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| Model No. | - | 1754V2 | |||
|---|---|---|---|---|---|
| Intended Use /Indications forUse: | [532nm single and 1064nm singlefunction in the Q-switched mode]With 1064nm single or 1064nmPDP function- Removal dark ink (black, blueand brown) tattoos- Treatment melasma- Treatment nevus of Ota- Treatment common nevi- Removal of lightening ofunwanted hair- Skin resurfacing procedures forthe treatment of acne scars andwrinklesWith 532nm single function- Removal of light ink (red, tan,purple, and orange) tattoos- Treatment of vascular lesionsincluding, but not limited toport-wine stains, telangiectasias,spider angioma, cherry angioma- Treatment of pigmented lesionsincluding, but not limited tocafe-au-Lait birthmarks, solarlentigines, senile lentigines,Becker's nevi, freckles, commonnevi, and nevus spilus- Treatment of seborrheickeratosis- Treatment of post-inflammatoryhyperpigmentation- Skin resurfacing procedures forthe treatment of acne scars andwrinkles[Non-Q-Switched function in theQ-Switched mode]With 1064nm Non-QSW function- Removal of unwanted hair, forstable long term or permanent | [Indications for use of Q-switchedNd:YAG Laser]1064 nm(including RTP 1064mode):- Incision, excision, ablation,vaporization of soft tissue forgeneral dermatology- Removal or lightening ofunwanted hair with or withoutadjuvant preparation- Treatment melasma- Treatment of Pigmented Lesionsnevus of ota- Skin resurfacing procedures forthe treatment of acne scars andwrinkles- Tattoo Removaldark ink: black, blue and brown532 nm:- Treatment of Vascular Lesionsport wine birthmarkstelangiectasiasspider angiomacherry angiomaspider nevi- Treatment of Pigmented Lesionscafé-au-Lait birthmarkssolar lentiginessenile lentiginesbecker's nevifrecklesnevus spilus- Skin resurfacing procedures forthe treatment of acne scars andwrinkles - Tattoo Removal light ink: red, sky blue, green,tan, purple, and orange | hair reduction and treatment ofPFB (Pseudofolliculitis Barbae).The laser is indicated for all skintypes, Fitzpatrick I-VI, includingtanned skin- Photocoagulation andhemostasis of pigmented andvascular lesions, such as but notlimited to port wine stains,cherry angioma, Hemangiomas,warts, telangiectasias, rosacea,leg veins, and spider veins- Coagulation and hemostasis ofsoft tissue- Treatment of wrinkles | [Indications for use of FR modein Nd:YAG Laser]- Removal of unwanted hair, forstable long term or permanenthair reduction and treatment ofPFB (Pseudofolliculitis Barbae).The laser is indicated for all skintypes, Fitzpatrick I-VI, includingtanned skin- Photocoagulation andhemostasis of pigmented andvascular lesions, such as but notlimited to port wine stains,cherry angioma, Hemangiomas,warts, telangiectasias, rosacea,leg veins, and spider veins- Coagulation and hemostasis ofsoft tissue- Treatment of wrinkles[Indications for use ofTi:Sapphire Laser]785 nm:- Removal of tattoos forFitzpatrick skin types II-IV totreat the following tattoo colors:green and blue.Q-switched Nd:YAG Laser andTi:Sapphire Laser cannot beused simultaneously. | |
| Wavelength | 1064 nm, 532 nm | 1064 nm, 532 nm, 785 nm | |||
| Pulse Duration(max) | <25 ns @ 1064 single (Q-switched mode)<25 ns @ 532 single (Q-switchedmode)<25ns @ PDP mode(1064 nm)300 us @ non-Q switchedmode(1064 nm) | 5-10 ns @ 1064 nm5-10 ns @ 532 nm600 ps @ 785 nm5-10 ns @ RTP mode(1064nm)300 us @ FR mode(1064 nm) |
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510(k) Summary
{11}------------------------------------------------
| Pulse Energy(max) | 1.6 J @ 1064nm0.5 J @ 532nm2.2 J @ PTP mode(1064 nm)3.5 J @ Non-Q mode(1064 nm) | 1.4 J @ 1064 nm0.5 J @ 532 nm0.2 J @ 785 nm2.0 J @ RTP mode(1064 nm)3.0 J @ FR mode(1064 nm) |
|---|---|---|
| Spot size (mm) | - Collimator Handpiece8 mm (1064 nm)- Zoom Handpiece2 | - Zoom Collimator (1064, 532 nm)5 |
| Repetition Rate | Unknown | 1-10 @ 1064 nm1-10 @ 532 nm1-10 @ 785 nm |
4 Device Description
The flash lamp as a laser pumping source converts electric energy to light energy when a high voltage is applied. Nd:YAG crystal with the specific resonator emits an 1064nm single wavelength laser by absorbing light energy from the flash lamp. Q-switching mode is applied to the 1064nm laser resonator to amplify the 1064nm laser with about 10ns short pulse width.
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510(k) Summary K243780
The amplified O-switched 1064nm laser is secondarily amplified by an another Nd: YAG crystal and, then is converted to a second harmonic 532nm laser by passing through KTP crystal.
Finally a 785nm laser is emitted by the 785nm cavity with Ti:Sapphire crystal using the 532nm laser as a laser pumping source.
HELIOS 785 Pico Laser System can emit 1064nm, 532nm, and 785nm laser selectively by switching the wavelength conversion optical modules. The 1064nm laser is emitted by only Nd: Y AG crystal resonator and the 532nm laser can be emitted with the 1064nm laser and KTP crystal. The 785nm laser can be emitted by all optical modules.
The Q-switch mode normally produces polarized light, but it is also possible to set the FR(Free Running) mode, which emits light in all directions by removing the optics of the Q-switch module. Additionally, the RTP(Real Twin Pulse) mode can be set to generate two identical pulses with a very short interval instead of a single pulse.
The HELIOS 785 Pico laser system consists of:
a) A high voltage power supply, which converts and rectifies Alternating Current (AC) to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.
c) The micro processor based controller unit, which regulates the functions of both lasers and allows parameter selection by the user.
d) The Nd: YAG laser + Ti:sapphire laser head.
5 Indications / Intended Use
[Indications for use of Q-switched Nd:YAG Laser]
1064 nm(including RTP 1064 mode):
- Incision, excision, ablation, vaporization of soft tissue for general dermatology
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Treatment melasma
- Treatment of Pigmented Lesions
- nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
dark ink: black, blue and brown
532 nm:
- Treatment of Vascular Lesions
- port wine birthmarks
- telangiectaias
- spider angioma
- cherry angioma
- spider nevi
- Treatment of Pigmented Lesions
{13}------------------------------------------------
café-au-lait birthmarks solar lentiginos senile lentiginos becker's nevi freckles
nevus spilus
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
light ink: red, sky blue, green, tan, purple, and orange
[Indications for use of FR mode in Nd:YAG Laser]
- Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofolliculitis Barbae). The laser is indicated for all skin types, Fitzpatrick I-VI. including tanned skin
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins
- Coagulation and hemostasis of soft tissue
- Treatment of wrinkles
[Indications for use of Ti:Sapphire Laser] 785 nm:
- Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
*Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously *
6 Performance Data
Non-clinical tests: Performance, such as safety of laser product, electromagnetic compatibility
and electrical safety, etc, were tested using following consensus standards:
- Basic safety and essential performance is tested and evaluated according to the -FDA-recognized consensus standard, ES 60601-1.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2.
- -Safety of laser product is evaluated in accordance with IEC 60825-1: 2014.
- -Risk management was recorded by referring to ISO 14971.
- Usability was documented by referring to IEC 60601-1-6. -
- Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment is evaluated in accordance with IEC 60601-2-22.
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510(k) Summary
7 Substantial Equivalence
The proposed device uses similar or identical technology as the predicate devices and has same intended uses. Based upon the predicted overall performance characteristics for HELIOS 785 Pico, Laseroptek Co., Ltd.. believes that no significant differences in usage of its underlying technological principles between HELIOS 785 Pico and the predicate device.
8 Conclusions
On the basis of the information provided in this Summary, Laseroptek Co., Ltd. believes that HELIOS 785 Pico (1754V2) is substantially equivalent to legally commercialized predicate devices (K230373 and K202288) for the purposes of this 510 (k) submission.
§ 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.