(247 days)
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) port wine birthmarks (532 nm) telangiectasias (532 nm) spider angioma (532 nm) cherry angioma (532 nm) spider nevi (532 nm) cafe-au-lait birthmarks (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles, nevus spilus (532 mm) nevus of ota (1064 nm)
The Helios III laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd–YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.
The provided text is a 510(k) summary for the Helios III Q-Switched Nd:YAG Laser System. It is an FDA submission seeking substantial equivalence to existing predicate devices, not a study proving the device meets specific acceptance criteria through clinical or AI-driven performance metrics.
The document primarily focuses on bench testing and comparison of technical specifications and intended uses with predicate devices to demonstrate substantial equivalence, rather than providing the kind of performance data you are asking for regarding AI/human reader studies.
Therefore, many of the requested items (e.g., acceptance criteria for AI performance, sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) are not applicable (N/A) because this is not a submission for an AI/ML medical device or a clinical outcome study in the traditional sense you have described.
Here's a breakdown of the information that is available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide explicit "acceptance criteria" in the format of pass/fail thresholds for clinical or AI performance. Instead, it presents a comparison of the Helios III's technical specifications and intended uses against two predicate devices recognized as legally marketed. The "performance" is demonstrated by showing that these specifications are comparable to or within acceptable ranges of the predicates.
Table 1: Approved Indication of Uses for Helios III Predicate Devices (Comparative)
| Feature / Criteria | Predicate Device (RevLite K133254) | Predicate Device (Helios II K083203) | Proposed Device (Helios III K152856) |
|---|---|---|---|
| Intended Use / Indications for Use: | Tattoo Removal: dark ink (blue and black), light ink (red, sky blue, green)Dermal pigmented lesions: Nevus of Ota, Lentigines, Nevi, Melasma, Café-au-lait, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosisHair Removal/Lightening: with or without adjuvant preparationSkin resurfacing: for acne scars and wrinklesBenign cutaneous lesions: (excluding 650 nm wavelength) striae and scarsReduction of red pigmentation: in hypertrophic and keloid scars where vascularity is integral (excluding 650 nm wavelength)Vascular lesions: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi | Tattoo Removal: dark ink (blue and black), light ink (red, sky blue, green)Dermal pigmented lesions: Nevus of Ota, Café-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, freckles, and Nevus spilusHair Removal/Lightening: with or without adjuvant preparationSoft tissue treatment: Incision, excision, ablation, vaporization for general dermatologyVascular lesions: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, and spider nevi | Tattoo Removal: dark ink (blue and black), light ink (red, sky blue, green)Dermal pigmented lesions: Nevus of Ota, Café-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, freckles, and Nevus spilusHair Removal/Lightening: with or without adjuvant preparationSoft tissue treatment: Incision, excision, ablation, vaporization for general dermatologyVascular lesions: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, and spider nevi |
Table 2: Performance Specification Comparison with Predicate Devices (Comparative)
| Feature / Criteria | Predicate Device (RevLite K133254) | Predicate Device (Helios II K083203) | Proposed Device (Helios III K152856) |
|---|---|---|---|
| Laser Medium | Nd:YAG | Nd:YAG | Nd:YAG |
| Operating Parameters | Q-Switched | Q-Switched | Q-Switched |
| Wavelength | 1064 nm / 532 nm | 1064 nm / 532 nm | 1064 nm / 532 nm |
| Maximum Pulse Duration | 7 – 20 ns | 8 ns | 10 ns |
| Energy Delivered | 1.6 J | 1 J (0.5 J @ 532 nm) / pulse | 1.3 J (0.5J @ 532 nm) / pulse |
| Fluence | 1 – 8 J/cm² @ 3 – 8 mm spot size | 1 – 8 J/cm² @ 1 to 7 mm spot size | 1 - 8 J/cm² @ 1 to 8 mm spot size |
| Spot Sizes | 2 – 8.5 mm range with 0.1 mm increments | 1 – 7 mm | (1064) 5 mm(532) 4 mm(Collimator) 8 mm(Zoom) 1~7 mm |
| Repetition Rate | Single shot, 1 - 10 Hz | Single Shot, 1 - 10 Hz | Single Shot, 1 - 10 Hz |
| Average Power (Max) | 10 W (5 W @ 532 nm) | 10 W (5 W @ 532 nm) | 13 W (5W @ 532 nm) |
| System Dimensions (H x W x D) | 31.8" x 12" x 28.5" | 37.2" x 13" x 37.2" | 36.8" x 11.7" x 32.2" |
| System Weight | 131 lbs. | 154 lbs. | 176 lbs. |
| Electrical Requirements | AC 230 V, 50/60 Hz | AC 230 V, 50/60 Hz | AC 230 V, 50/60 Hz |
| Maximum Power | 20W | 20 W | 20W |
Regarding the Study:
The document states:
- Performance Data: "Non-clinical testing of Helios III included visual and mechanical inspection, electrical and mechanical safety testing, functional performance testing, etc., in bench. Some of these tests include visual inspection, earthbond testing, software testing, transit testing, leakage current testing and measurements. Test reports have been submitted."
- This refers to bench testing for safety and functional performance as a laser device, not a comparative clinical study or AI performance evaluation.
Specific Answers to Your Questions (based on the provided text):
- Sample sizes used for the test set and the data provenance: N/A. This document describes non-clinical bench testing of a laser device, not performance on a test set of medical images or patient data. Data provenance (country, retrospective/prospective) is also N/A for this type of submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment by experts is not described for this type of device submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. No adjudication process for a test set is mentioned.
- 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: N/A. This is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A. For the bench testing, "ground truth" would be the engineering specifications and safety standards met by the device.
- The sample size for the training set: N/A. This device does not involve a training set as it is not an AI/ML product.
- How the ground truth for the training set was established: N/A. Not an AI/ML product.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2016
Laseroptek Co. Ltd. Mr. Kevin J. Choi 28 Stafford Drive West Windsor, NJ 08550
Re: K152856 Trade/Device Name: Helios III 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 5, 2016 Received: April 12, 2016
Dear Mr. Choi:
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. 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152856
Device Name
Helios III O-Switched Nd:YAG Laser System
Indications for Use (Describe)
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) port wine birthmarks (532 nm) telangiectasias (532 nm) spider angioma (532 nm) cherry angioma (532 nm) spider nevi (532 nm) cafe-au-lait birthmarks (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles, nevus spilus (532 mm) nevus of ota (1064 nm)
| 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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This 510(k) Summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR §807.92
| Submitter's Information | |
|---|---|
| Applicant: | Laseroptek Co. Ltd. |
| Address: | 204 Hyundai I Valley223-12 Sangdaiwon, JungwonSungnam-Si, Gyeonggido, 462-714Rep. of Korea (South Korea) |
| Contact Person: | Hong Chu, Ph.D. (President & CEO) |
| Telephone / Fax / E-mail: | Tel) +82.31.737.9885E-mail) hchu@laseroptek.com |
| Submitter: | Kevin Choi |
| Address: | 28 Stafford Drive, West Windsor, NJ 08850 |
| Contact Person: | Kevin J. Choi |
| Telephone / Fax / E-Mail: | Tel) 310-634-4480E-mail) kjchoi1128@hotmail.com |
| Preparation Date: | 07/17/2015 |
| Device Trade Name: | Helios III |
| Common Name: | Q-Switched Nd:YAG Laser |
| Classification Name: | Instruments, Surgical, Powered, Laser 79-GEX(21 CFR §878-4810) |
| Legally Marketed Predicate Devices: | • Cynosure, Inc.'s Revlite Q-Switched Nd:YAGLaser System (K133254)• Laseroptek Co. Ltd.'s Helios II Q-Switched |
Nd:YAG Laser System (K083203)
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Intended Use of Helios III: The Helios III Q-Switched Nd:YAG Laser System delivers pulse wave laser light in the contact or noncontact mode for; Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Removal or lightening of unwanted hair with or without adjuvant preparation (1064 nm) 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) Device Description: The Helios III laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping
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| light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd–YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit. | |
|---|---|
| The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply. | |
| Performance Data: | Non-clinical testing of Helios III included visual and mechanical inspection, electrical and mechanical safety testing, functional performance testing, etc., in bench. Some of these tests include visual inspection, earthbond testing, software testing, transit testing, leakage current testing and measurements. Test reports have been submitted. |
| Substantial Equivalence | Helios III's intended use is identical to the intended use of the predicate devices: Cynosure, Inc.'s Revlite Q-Switched Nd:YAG Laser System (K133254) and Laseroptek Co. Ltd.'s Helios II Q-Switched Nd:YAG Laser System (K083203) |
| Comparison of indications for use and performance specifications are provided in the following tables. |
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510(k) Summary Helios III Q-Switched Nd:YAG Laser
| Predicate Device | Predicate Device | Proposed Device | |
|---|---|---|---|
| 510(K) Number | K133254 | K083203 | K152856 |
| Manufacturer | Cynosure (HOYA ConBio) | Laseroptek Co. Ltd. | Laseroptek Co. Ltd. |
| Device Name | RevLite Q-Switched Nd:YAG Laser System | Helios II Q-Switched Nd:YAG Laser System | Helios III Q-Switched Nd:YAG Laser System |
| Intended Use /Indications for Us: | Tattoo Removal (dark ink: blue and black) | Tattoo Removal (dark ink: blue and black) | Tattoo Removal (dark ink: blue and black) |
| Dermal pigmented lesions, including, butnot limited to: Nevus of Ota, Lentigines,Nevi, Melasma and Café-au-lait | Dermal pigmented legions: Nevus of Ota,Café-au-lait birthmarks, solar lentiginos,senile lentiginos, becker's nevi, freckles,and nevus spilus | Dermal pigmented legions: Nevus of Ota,Café-au-lait birthmarks, solar lentiginos,senile lentiginos, becker's nevi, freckles,and nevus spilus | |
| Removal or lightening of hair with orwithout adjuvant preparation | Removal or lightening of hair with orwithout adjuvant preparation | Removal or lightening of hair with orwithout adjuvant preparation | |
| Skin resurfacing for acne scars and wrinkles | Incision, excision, ablation, vaporization ofsoft tissue for general dermatology | Incision, excision, ablation, vaporization ofsoft tissue for general dermatology | |
| Benign cutaneous lesions: including, butnot limited to; striae and scars (excludesthe 650 nm wavelength) | Tattoo Removal (light ink: red, sky blue,green) | Tattoo Removal (light ink: red, sky blue,green) | |
| Reduction of red pigmentation inhypertrophic and deloid scars wherevascularity is an integral part of the scar(excludes the 650 nm wavelength) | Treatment of vascular lesions: port wine,birthmarks, telangiectasias, spiderangioma, cherry angioma, and spider nevi | Treatment of vascular lesions: port wine,birthmarks, telangiectasias, spiderangioma, cherry angioma, and spider nevi | |
| Tattoo Removal (light ink: red, sky blue,green) | |||
| Vascular lesions including but not limitedto: port wine, birthmarks, telangiectasias,spider angioma, cherry angioma, spidernevi | |||
| Epidermal pigmented lesions; including,but not limited to: café-au-lait birthmarks,solar lentiginos, senile lentiginos, Becker'snevi, Freckles, Nevus spilus, seborrheickeratosis | |||
| Skin resurfacing for acne scars and wrinkles | |||
| Benign cutaneous lesions; including, butnot limited to: striae and scars (excludesthe 650 nm wavelength) | |||
| Reduction of red pigmentation inhypertrophic and deloid scars wherevascularity is an integral part of the scar(excludes the 650 nm wavelength) |
Table 1: Approved Indication of Uses for Helios III Predicate Devices
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| Predicate Device | Predicate Device | Proposed Device | |
|---|---|---|---|
| 510(K) Number | K133254 | K083203 | K152856 |
| Manufacturer | Cynosure (HOYA ConBio) | Laseroptek Co. Ltd. | Laseroptek Co. Ltd. |
| Device Name | RevLite Q-Switched Nd:YAG Laser System | Helios II Q-Switched Nd:YAG Laser System | Helios III Q-Switched Nd:YAG Laser System |
| Clearance Date: | 3/5/2014 | 4/28/2009 | Not Available |
| Classification / Regulation | 21 CFR 878.4810 (GEX) | 21 CFR 878.4810 (GEX) | 21 CFR 878.4810 (GEX) |
| Laser Medium | Nd:YAG | Nd:YAG | Nd:YAG |
| Operating Parameters | Q-Switched | Q-Switched | Q-Switched |
| Wavelength | 1064 nm / 532 nm | 1064 nm / 532 nm | 1064 nm / 532 nm |
| Pulse Characteristics: | |||
| Maximum Pulse Duration | 7 – 20 ns | 8 ns | 10 ns |
| Energy Delivered | 1.6 J | 1 J (0.5 J @ 532 nm) / pulse | 1.3 J (0.5J @ 532 nm) / pulse |
| Fluence | 1 – 8 J/cm2 @ 3 – 8 mm spot size | 1 – 8 J/cm2 @ 1 to 7 mm spot size | 1 - 8 J/cm2 @ 1 to 8 mm spot size |
| Spot Sizes | 2 – 8.5 mm range with 0.1 mm increments | 1 – 7 mm | (1064) 5 mm(532) 4 mm(Collimator) 8 mm(Zoom) 1~7 mm |
| Repetition Rate | Single shot, 1 - 10 Hz | Single Shot, 1 - 10 Hz | Single Shot, 1 - 10 Hz |
| Average Power (Max): | 10 W (5 W @ 532 nm) | 10 W (5 W @ 532 nm) | 13 W (5W @ 532 nm) |
| Physical Characteristics: | |||
| System Dimensions | 31.8"(H) X 12" (W) X 28.5" (D) | 37.2"(H) X 13"(W) X 37.2 (D) | 36.8"(H) X 11.7"(W) X 32.2" (D) |
| System Weight | 131 lbs. | 154 lbs. | 176 lbs. |
| Electrical Requirements | AC 230 V, 50/60 Hz | AC 230 V, 50/60 Hz | AC 230 V, 50/60 Hz |
| Maximum Power | 20W | 20 W | 20W |
Table 2: Performance Specification Comparison with Predicate Devices
Conclusion
The Helios III Q-Switched Nd:YAG Laser System is substantially equivalent to other existing systems in commercial distribution for treatment of the intended use indications share very similar / exactly same performance specification parameters as noted in above table.
§ 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.