(98 days)
No
The document describes a laser system with an embedded processor for control, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as treating various medical conditions such as benign vascular lesions, benign pigmented lesions, and is also used for incision, excision, ablation, and vaporization of soft tissue for general dermatology, which fall under therapeutic applications. Furthermore, the performance studies mention "Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment" standards.
No
Explanation: The device is described as performing incision, excision, ablation, vaporization, and removal/treatment of various skin conditions and tattoos, which are therapeutic and aesthetic procedures, not diagnostic ones. Although it mentions cosmetic, therapeutic, and diagnostic laser equipment standards (IEC 60601-2-22:2012), its listed indications for use are exclusively therapeutic.
No
The device description explicitly states it consists of hardware components including a main body, color touch screen, articulated arm, foot switch, handpieces, and an embedded processor, and delivers thermal energy using focusing optics. This is not a software-only device.
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, vaporization, hair removal, tattoo removal, treatment of benign vascular and pigmented lesions). IVDs are used to diagnose diseases or conditions by examining samples from the human body (like blood, urine, tissue).
- Device Description: The device description details a laser system that delivers thermal energy to the skin. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples 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 (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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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.
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 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
2
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
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 Laser | |
| System | ||
| Classification Name: | Powered Laser Surgical Instrument | |
| Regulation Name: | Laser surgical instrument for use in general and plastic | |
| surgery 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 Laser | |
| System | Syneron Candela | ||
| Corporation |
4. 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.
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)
5
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) | 1064 | |
| 532 | 1064 | |
| 532 | ||
| (Accuracy ±20%) | 785 | 785 |
| Pulse Duration (max) | 5-10 ns @ 1064 nm | |
| 5-10 ns @ 532 nm | ||
| 600 ps @ 785 nm | 5-10 ns @ 1064 nm | |
| 5-10 ns @ 532 nm | ||
| 600 ps @ 785 nm | ||
| Pulse Energy (max) | 1.4 J @ 1064 nm | |
| 0.5 J @ 532 nm | ||
| 0.2 J @ 785 nm | 1.4 J @ 1064 nm | |
| 0.5 J @ 532 nm | ||
| 0.2 J @ 785 nm | ||
| Fluence (J/cm², max)* | 8 @ 1064nm | |
| 8 @ 532 nm | ||
| 4 @ 785 nm | 8 @ 1064nm | |
| 8 @ 532 nm | ||
| 4 @ 785 nm | ||
| Peak Power (GW) | 0.28 @ 1064 nm | |
| 0.1 @ 1064 nm | ||
| 0.33 @ 785 nm | 0.28 @ 1064 nm | |
| 0.1 @ 1064 nm | ||
| 0.33 @ 785 nm |
Comparison of Technology:
6
| 510(k) Summary | ||
|---|---|---|
| Max. Average Power (W) | 14 @ 1064 nm | |
| 5 @ 1064 nm | ||
| 2 @ 785 nm | 14 @ 1064 nm | |
| 5 @ 1064 nm | ||
| 2 @ 785 nm | ||
| Spot Size (mm) | 1-10 @ 1064 nm | |
| 1-10 @ 532 nm | ||
| 1-8 @ 785 nm | 1-10 @ 1064 nm | |
| 1-10 @ 532 nm | ||
| 1-8 @ 785 nm | ||
| Repetition Rate (Hz) | 1-10 @ 1064 nm | |
| 1-10 @ 532 nm | ||
| 1-5 @ 785 nm | 1-10 @ 1064 nm | |
| 1-10 @ 532 nm | ||
| 1-10 @ 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.