(456 days)
The LED FACIAL LIGHT THERAPY MASK (Model: HK207) is intended to:
- The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
- The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face writtles.
The FLEXIBLE LED LIGHT THERAPY (Model: HK209) is intended to:
- The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
- The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles
- The device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stifficess; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
LED FACIAL LIGHT THERAPY MASK (Model: HK207) is a home use wearable LED phototherapy device designed to fit the contours of the target areas of the anatomy, covered with a biocompatible material, which uses specific wavelengths of light to manage aesthetic conditions. This device produces light in the blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. The red light (640nm) in combination with infrared light (880nm) is intended to improve the appearance of wrinkles.
FLEXIBLE LED LIGHT THERAPY (Model: HK209) is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with a biocompatible material, which uses specific wavelengths of light to manage aesthetic conditions. This device produces light in the near-infrared region of the spectrum (880nm) intended to provide topical heating to temporary pain relief. Blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) in combination with infrared light (880nm) is intended to improve the appearance of wrinkles.
The provided document is a 510(k) summary for LED facial light therapy masks (Models HK207 and HK209). It details the device's characteristics and its comparison to predicate devices, but it does not contain information about a clinical study with acceptance criteria and reported device performance in the way typically expected for a diagnostic or AI-powered medical device.
Instead, the submission relies on demonstrating substantial equivalence to previously cleared devices (predicates) by comparing technical, functional, and safety aspects. The "Test Summary" section primarily outlines bench tests conducted to ensure compliance with recognized electrical safety, electromagnetic compatibility, and biocompatibility standards. It explicitly states "Clinic test: N/A".
Therefore, I cannot provide the requested information regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement for a clinical study from this document.
However, I can extract the information related to the bench testing, which acts as the 'proof' that the device meets safety and performance standards for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance (Bench Tests):
| Test Category | Acceptance Criteria (Standard Complied With) | Reported Device Performance (Conclusion) |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (in vitro cytotoxicity) | Evaluated and presumably passed (submission states "safety and performance by lab bench testing") |
| ISO 10993-10:2010 (irritation and skin sensitization) | Evaluated and presumably passed (submission states "safety and performance by lab bench testing") | |
| Electrical Safety | IEC 60601-1:2005+A1:2012 (General Requirements) | Evaluated and presumably passed (submission states "safety and performance by lab bench testing") |
| EM Compatibility | IEC 60601-1-2:2014-02 (EMC) | Evaluated and presumably passed (submission states "safety and performance by lab bench testing") |
| Home Healthcare | IEC 60601-1-11:2015-01 (Home Healthcare Environment) | Evaluated and presumably passed (submission states "safety and performance by lab bench testing") |
| Light Source Equip. | IEC 60601-2-57:2011 (non-laser light source equipment for therapeutic/cosmetic use) | Evaluated and presumably passed (submission states "safety and performance by lab bench testing", also noted in "Comparison in Detail(s)") |
| Power Source | IEC 60601-2-57 requirements (implicitly for safety within USA area) | Compliant with IEC 60601-2-57 requirements; range of power source can be safely used in the USA area. (Note 2) |
| Treatment Area | IEC 60601-2-57 requirements (implicitly for safety and effectiveness despite shape variations) | Compliant with IEC 60601-2-57 requirements; shape differences do not affect safety and effectiveness. (Note 3) |
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 applicable as the document explicitly states "Clinic test: N/A" and relies on bench testing and comparison to predicates for safety and effectiveness. Bench tests typically involve testing a representative number of device units (physical samples), not patient data.
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 applicable as no clinical study with human data or ground truth established by experts was reported for this 510(k) submission. For bench testing, expertise would come from engineers, quality assurance personnel, and certified lab technicians according to the relevant standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical study requiring adjudication of findings was performed or reported.
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 applicable. This is not an AI-powered device, and no MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This is a light therapy device, not an algorithm, and its performance is assessed through its physical and electrical characteristics and light output, not through algorithmic standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" is defined by the specific requirements and measurement parameters outlined in the referenced international standards (e.g., ISO 10993, IEC 60601 series). Compliance with these standards indicates satisfactory performance.
8. The sample size for the training set
This information is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/machine learning device that requires a training set.
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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.
July 14, 2021
Ningbo Hesi Electric Co., Ltd Ms. Cassie Lee Guangzhou GLOOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong 511495 China
Re: K200983
Trade/Device Name: LED facial light therapy mask (Model: HK207), Flexible LED light therapy (Model: HK209) 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: OHS, OLP, ILY Dated: April 2, 2020 Received: April 14, 2020
Dear Cassie 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200983
Device Name
LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT THERAPY (Model: HK209)
Indications for Use (Describe)
The LED FACIAL LIGHT THERAPY MASK (Model: HK207) is intended to:
- The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
- The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face writtles.
The FLEXIBLE LED LIGHT THERAPY (Model: HK209) is intended to:
-
The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
-
The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles
-
The device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stifficess; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|---|---|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHTTHERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |
510(k) Summary of K200983
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor Name: NINGBO HESI ELECTRIC CO., LTD Establishment Registration Number: 3009784099 Address: NO.818-23-156 Qiming Rd, Yinzhou, Ningbo City Zhejiang, CHINA Postal code: 315000 Contact name: MA LULU (General Manager) Tel: 15825567078 Fax: 0574-88300553 E-mail: 463415782@gq.com
2. Date of the summary prepared: July 13, 2021
3. Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
4. Subject Device Information
Type of 510(k): Traditional Classification Name: Light Based Over-The Counter Wrinkle Reduction (OHS); Over-The-Counter Powered Light Based Laser For Acne (OLP); Lamp, Infrared, Therapeutic Heating (ILY) Trade Name: LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT THERAPY (Model: HK209) Review Panel: General & Plastic Surgery Product Code: OHS, OLP, ILY
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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|---|---|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHTTHERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |
Regulation Number: 890.5500, 878.4810 Regulatory Class: II
5. Predicate Device Information
| Sponsor | Biophotas, Inc | Biophotas, Inc |
|---|---|---|
| Device Name and Model | BioPhotas Celluma³ | BioPhotas Celluma³ |
| 510(k) Number | K152280 | K171323 |
| Product Code | ILY, OHS, OLP | OHS |
| Regulation Number | 890.5500, 878.4810 | 878.4810 |
| Regulation Class | II | II |
6. Device Description
LED FACIAL LIGHT THERAPY MASK (Model: HK207) is a home use wearable LED phototherapy device designed to fit the contours of the target areas of the anatomy, covered with a biocompatible material, which uses specific wavelengths of light to manage aesthetic conditions. This device produces light in the blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. The red light (640nm) in combination with infrared light (880nm) is intended to improve the appearance of wrinkles.
FLEXIBLE LED LIGHT THERAPY (Model: HK209) is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with a biocompatible material, which uses specific wavelengths of light to manage aesthetic conditions. This device produces light in the near-infrared region of the spectrum (880nm) intended to provide topical heating to temporary pain relief. Blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) in combination with infrared light (880nm) is intended to improve the appearance of wrinkles.
7. Intended Use / Indications for Use
The LED FACIAL LIGHT THERAPY MASK (Model: HK207) is intended to:
- The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
- -The device emitting enerqy in the red and infrared spectrum is intended for the treatment of full-face wrinkles.
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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|---|---|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHTTHERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |
The FLEXIBLE LED LIGHT THERAPY (Model: HK209) is intended to:
- -The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
- The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles
- The device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
8. Comparison to predicate device
Compare with predicate devices, the subject device is very similar in design principle, intended use, indications for use, functions, material, and the applicable standards. The differences between subject devices and predicate devices do not raise new questions of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
|---|---|---|---|---|
| Company | Ningbo Hesi ElectronicCo., Ltd | Biophotas, Inc | Biophotas, Inc | -- |
| Trade Name | LED FACIAL LIGHTTHERAPY MASK(Model: HK207),FLEXIBLE LED LIGHTTHERAPY (Model:HK209) | BioPhotas Celluma3 | BioPhotas Celluma3 | -- |
| 510(k) Number | K200983 | K152280 | K171323 | -- |
| Product Code | OHS, OLP, ILY | ILY, OHS, OLP | OHS | SE |
| Intended Use /Indications for Use | The LED FACIALLIGHT THERAPYMASK (Model: HK207)is intended to:- The deviceemitting energy in | The BioPhotas Celluma3is intended to deliverheat in the IR spectrumto provide topicalheating for the purposeof elevating tissue | The BioPhotasCelluma3is intended to emitenergy in the visibleandinfrared region of | SENote 1 |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
| the blue isintended to reducethe mild tomoderateinflammatory acnevulgaris. | temperature; for thetemporary relief of minormuscle and joint pain,arthritis and musclespasm; relievingstiffness; promoting therelaxation of muscletissue; and totemporarily increaselocal blood circulation. | thespectrum for use inthetreatment of full facewrinkles. | ||
| - The deviceemitting energy inthe red andinfrared spectrumis intended for thetreatment of full-face wrinkles.The FLEXIBLE LEDLIGHT THERAPY(Model: HK209) isintended to: | The blue spectrum lightis intended toreduce mild to moderateinflammatory acnevulgaris. The Celluma³is intended to emitenergy in the red andinfrared spectrum foruse in dermatology forthe treatment ofperiorbital wrinkles. | |||
| - The deviceemitting energy inthe blue isintended to reducethe mild tomoderateinflammatory acnevulgaris. | ||||
| - The deviceemitting energy inthe red andinfrared spectrumis intended for thetreatment of full- |
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Sponsor:
Subject Device:
Document Name: K number:
NINGBO HESI ELECTRIC CO., LTD LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT THERAPY (Model: HK209) 510(k) Summary K200983
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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|---|---|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHTTHERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
|---|---|---|---|---|
| face wrinkles- The device isintended to deliverheat in the IRspectrum toprovide topicalheating for thepurpose ofelevating tissuetemperature; forthe temporaryrelief of minormuscle and jointpain, arthritis andmuscle spasm;relieving stiffness;promoting therelaxation ofmuscle tissue; andto temporarilyincrease localblood circulation. | ||||
| RegulationNumber | 890.5500, 878.4810 | 890.5500, 878.4810 | 878.4810 | SE |
| Regulation Name | Light Based Over-TheCounter WrinkleReduction (OHS); Over-The-Counter PoweredLight Based Laser ForAcne (OLP); Lamp,Infrared, Therapeutic | Light Based Over-TheCounter WrinkleReduction (OHS); Over-The-Counter PoweredLight Based Laser ForAcne (OLP); Lamp,Infrared, Therapeutic | Light Based Over –The CounterWrinkle Reduction(OHS) | SE |
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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|---|---|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHTTHERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
|---|---|---|---|---|
| Heating (ILY) | Heating (ILY) | Heating (ILY) | ||
| Regulatory Class | Class II | Class II | Class II | SE |
| Treatment areas | Entire Face and body | Entire Face and body | Whole Face | SENote 3 |
| Intendedpopulation | Adult | Adult | Adult | SE |
| Power Source(s) | Input: 100 – 240Vac,2.0 A, 50/60Hz | 110 – 120V | 110-120V | SENote 2 |
| Wavelength(s)(nm) | 465nm, 640nm, 880nm | 465nm, 640nm, 880nm | Red: 640nm±25nmNIR: 880nm±50nm | SE |
| Irradiances(mW/cm²) | 6.5 mW/cm² | 6.5 mW/cm² | 6.5 mW/cm² | SE |
| Treatment Dose(J/cm²) | 11.7 J/cm² | 11.7 J/cm² | 11.7 J/cm² | SE |
| Treatment time | 3 times a week for 30min.4 weeks | 3 times a week for 30min.4 weeks | 3 treatments perweek(1800 seconds)4 weeks | SE |
| The distancebetween the LEDsto treatmentsurface | For model: HK207 0.5-3cmFor model: HK209 10cm | As closed to the skin | As closed to the skin | SE |
| Irradiation area | HK207: 510 cm²HK209: 890 cm² | 820 cm² | 15" x 8" | SENote 3 |
| Electrical safety | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | SE |
Comparison in Detail(s):
Note 1:
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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|---|---|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHTTHERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |
Although the Intended Use is slightly different from the predicate devices in the description, we can find that the subject device emits the same wavelengths and the same intended purpose as the predicate device. So, the slight differences will not raise any safety or effectiveness issues.
Note 2:
Although the "Power Source(s)" of the subject device is a little different from the predicate devices, they are all compliant with IEC 60601-2-57 requirements and the range of power source can be safely used in the USA area. So, the differences will not raise any safety or effectiveness issues.
Note 3:
Although the "Treatment area" is a little different from the predicate devices, it's just the factor depends on the shape of the product which will not affect the safety and effectiveness, and they all compliant with IEC 60601-2-57 requirements. So, the differences will not raise any safety or effectiveness issues.
9. Test Summary
- Bench test:
The LED FACIAL LIGHT THERAPY MASK (Model: HK207) and FLEXIBLE LED LIGHT THERAPY (Model: HK209) have been evaluated the safety and performance by lab bench testing as following:
- � ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity. (Biocompatibility).
- � ISO 10993-10 2010, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization. (Biocompatibility).
- � IEC 60601-1: 2005+A1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance .
- � IEC 60601-1-2: 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility.
- � IEC 60601-1-11 (Edition2.0): 2015-01, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- � IEC 60601-2-57 (First Edition): 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of non-
{10}------------------------------------------------
| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|---|---|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHTTHERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |
laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- Clinic test
N/A
10. Conclusion:
The subject device K200983 "LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT THERAPY (Model: HK209)" is Substantial Equivalent to the predicate devices K152280 and K171323.
§ 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.