(129 days)
This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Using traditional UV light with the combination of red and blue light the user indulges in a new luxurious tanning experience. Optimal tanning results are achieved due to the synergistic combination of light spectra.
The provided text is a 510(k) Summary of Safety and Effectiveness for sunlamp products. It details comparisons between proposed devices and legally marketed predicate devices to demonstrate substantial equivalence, rather than providing an acceptance criteria table and a study proving a device meets those criteria in the context of an AI/algorithm-driven medical device.
The document does not contain information relevant to AI/algorithm performance, ground truth establishment, sample sizes for training/test sets, or expert review processes for such devices. Therefore, I cannot generate the requested table and study description based on the provided text.
The text focuses on hardware comparison and compliance with established performance standards for sunlamp products (e.g., IEC 60601-1 for electrical and mechanical safety, IEC 60601-1-2 for EMC, and U.S. performance standard 21CFR 1040.20 for irradiance ratio).
To summarize why I cannot fulfill your request:
- No AI/Algorithm Component: The submitted document describes sunlamp products, which are physical devices. There is no mention of any AI component, algorithm, or software that would require performance evaluation metrics like sensitivity, specificity, or AUC, nor would it involve concepts like "ground truth" derived from expert consensus or pathology for diagnostic purposes.
- Performance Testing Focus: The "Summary of performance testing" section clearly states that the devices were tested for "biocompatibility," "electrical and mechanical safety," and "EMC," and compliance with "U.S. performance standard 21CFR 1040.20" (which pertains to sunlamp products and their UV emissions). These are physical device performance criteria, not AI/algorithm performance.
- Comparative Approach: The entire document is structured as a comparison (substantial equivalence) to predicate devices, demonstrating that new models are similar in technology, intended use, and safety to already cleared devices, rather than a novel device proving its effectiveness against a set of performance criteria through a clinical study.
Therefore, the requested information (Acceptance Criteria Table, Sample Sizes for Test/Training, Expert Ground Truth, Adjudication, MRMC study, Standalone performance, Type of Ground Truth, Training Set Size, Training Ground Truth) is not present in the provided document because it describes a different type of medical device lacking an AI/algorithm component.
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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.
July 1, 2022
JK-Holding GmbH Juergen Gerstenmeier Official Applicant Koehlershohner Strasse 60 Windhagen, Rheinland-Pfalz 53578 Germany
Re: K220500
Trade/Device Name: Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline Regulation Number: 21 CFR 878.4635 Regulation Name: Sunlamp products and ultraviolet lamps intended for use in sunlamp products Regulatory Class: Class II Product Code: LEJ Dated: May 20, 2022 Received: May 31, 2022
Dear Juergen Gerstenmeier:
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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Indications for Use
510(k) Number (if known) K220500
Device Name
Ergoline Vitality Total Light, Ergoline Vitality Hybrid Light, Ergoline Vitality Pure Light, Planet Fitness TLT by Ergoline, Planet Fitness HLT by Ergoline, Planet Fitness PLT by Ergoline
Indications for Use (Describe)
This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
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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Chapter 5 510(k) Summary of Safety and Effectiveness
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510(k) Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act, JK-HOLDING GmbH herewith submits a Summary of Safety and Effectiveness.
This 510(k) summary includes the bundles for device trade names for Ergoline Vitality Total Light, Ergoline Vitality Hybrid Light, Ergoline Vitality Pure Light, Planet Fitness TLT by Ergoline, Planet Fitness HLT by Ergoline, Planet Fitness PLT by Ergoline & variant units which meet the requirements of 21 CFR 807.92
| Manufacturer Information: | JK-Produkts GmbHRottbitzer Strasse 6953604 Bad HonnefGermanyPhone: +49 (0) 2224 / 818-140Fax: +49 (0) 2224 / 818-166 |
|---|---|
| Establishment Registration Number: 9615023Owner/Operator Number: 9034303 | |
| Submitter Information: | JK-HOLDING GmbHKoehlershohner Strasse 6053578 WindhagenPhone: +49 (0) 2224 / 818-0Fax: +49 (0) 2224 / 818-116 |
| Official Correspondent: | Juergen GerstenmeierKoehlershohner Strasse 6053578 WindhagenGermanyPhone: +49 (0) 2224 / 818-330Email: juergen.gerstenmeier@jk-group.net |
| US Agent (Contact): | Marie MerrillJK PRODUCTS & SERVICES, INC.411 West Washington Ave Suite BJonesboro , AR 72401Phone: 870 761 8906Fax: 870 9359046Email: marie.merrill@jkamerica.com |
| Device trade name: | Ergoline Vitality Total Light 3Planet Fitness 50/4 TLT by ErgolinePlanet Fitness 42/3 TLT by ErgolineErgoline Vitality Hybrid Light 3Ergoline Vitality Hybrid LightPlanet Fitness 50/4 HLT by ErgolinePlanet Fitness 46/3 HLT by Ergoline |
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Ergoline Vitality Pure Light 3 Ergoline Vitality Pure Light Planet Fitness 50/4 PLT III by Ergoline Planet Fitness 50/4 PLT by Ergoline Planet Fitness 46/3 PLT by Ergoline Planet Fitness 42/3 PLT by Ergoline
Date Prepared: February 16th, 2022
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Table of contents
| 1 | Table of contents | 5 | |
|---|---|---|---|
| 1.1 | Device(s) Identification: | 5 | |
| 1.1.1 | Indications for use: | 5 | |
| 1.1.2 | Classification of all proposed device: | 6 | |
| 1.2 | Device trade name of bundle 1: | 6 | |
| 1.2.1 | Device Description: | 6 | |
| 1.2.2 | Legally marketed predicate device: | 7 | |
| Legally marketed technical referenced device: | 7 | ||
| 1.2.3 | Comparison bundle 1 to predicate device: | 8 | |
| 1.2.4 | Summary of performance testing: | 12 | |
| 1.2.5 | Conclusion: | 13 | |
| 1.3 | Device trade name of bundle 2: | 13 | |
| 1.3.1 | Device description: | 13 | |
| 1.3.2 | Legally marketed predicate device 2: | 14 | |
| 1.3.3 | Comparison bundle 2 to predicate device: | 15 | |
| 1.3.4 | Summary of performance testing: | 17 | |
| 1.3.5 | Conclusion: | 17 | |
| 1.4 | Device trade name of bundle 3: | 17 | |
| 1.4.1 | Device description: | 17 | |
| 1.4.2 | Legally marketed predicate device: | 18 | |
| Legally marketed technical referenced device: | 18 | ||
| 1.4.3 | Comparison bundle 3 to predicate device: | 19 | |
| 1.4.4 | Summary of performance testing: | 27 | |
| 1.4.5 | Conclusion: | 27 | |
| 1.5 | Device trade name of bundle 4: | 27 | |
| 1.5.1 | Device description: | 28 | |
| 1.5.2 | Legally marketed predicate device 4: | 28 | |
| 1.5.3 | Comparison bundle 4 to predicate device: | 29 | |
| 1.5.4 | Summary of performance testing: | 32 | |
| 1.5.5 | Conclusion: | 32 | |
| 1.6 | Device trade name of bundle 5: | 32 | |
| 1.6.1 | Device Description: | 33 | |
| 1.6.2 | Legally marketed predicate device 5: | 33 | |
| 1.6.3 | Comparison bundle 5 to predicate device: | 34 | |
| 1.6.4 | Summary of performance testing: | 39 | |
| 1.6.5 | Conclusion: | 39 |
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1.1 Device(s) Identification:
In the following, 5 different bundles of devices will be presented and evaluated.
| Bundle No | Model No | Device names |
|---|---|---|
| 1 | JK 164 / 42-3 TLT-3 ACJK 164 / 42-3 TLT-3JK 164 / 42-3 TLT ACJK 164 / 42-3 TLT | Planet Fitness 42/3 TLT by ErgolineErgoline Vitality Total Light 3 |
| 2 | JK 164 / 42-3 PLT ACJK 164 / 42-3 PLT | Planet Fitness 42/3 PLT by ErgolineErgoline Vitality Pure Light |
| 3 | JK 164 / 50-4 TLT-3 TTJK 164 / 50-4 TLT-3JK 164 / 50-4 HLT-3 TTJK 164 / 50-4 HLT-3JK 164 / 50-4 TLT TTJK 164 / 50-4 TLT ACJK 164 / 50-4 TLT | Planet Fitness 50/4 TLT by ErgolineErgoline Vitality Total Light 3Planet Fitness 50/4 HLT by ErgolineErgoline Vitality Hybrid Light 3 |
| 4 | JK 164 / 50-4 PLT-3 ACJK 164 / 50-4 PLT-3JK 164 / 50-4 PLT ACJK 164 / 50-4 PLT | Planet Fitness 50/4 PLT III by ErgolineErgoline Vitality Pure Light 3Planet Fitness 50/4 PLT by ErgolineErgoline Vitality Pure Light |
| 5 | JK 164 / 46-3 PLT ACJK 164 / 46-3 PLTJK 164 / 46-3 HLT ACJK 164 / 46-3 HLT | Planet Fitness 46/3 PLT by ErgolineErgoline Vitality Pure LightPlanet Fitness 46/3 HLT by ErgolineErgoline Vitality Hybrid Light |
All products have an identical intended use and comparable technology.
The different devices in the bundles have different trade names, number of lamps, a different combination of light spectra and different maximum exposure times.
The basic products can be upgraded with conversion kits, consisting of stickers with the private label naming, to Soltron or further private label sunlamp products. The conversion kit only serves to label the basic product as a Soltron or further private label sunlamp product. It does not alter any technical specification or aspect of the devices.
For further information concerning conversion kits please refer to chapter 11.
1.1.1 Indications for use:
This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
1.1.2 Classification of all proposed device:
| Device Classification Name: | Booth, Sun Tan |
|---|---|
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
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1.2 Device trade names of bundle 1:
Planet Fitness 42/3 TLT by Ergoline Ergoline Vitality Total Light 3
Common name: Sunlamp product
The following table presents the different variants of the JK 164 / 42-3 Total Light Technology sunlamp product.
All variants use the same basic device technology and differ only in private labelling, exterior design, decor lighting and comfort features.
| Model-No. | Variant Name |
|---|---|
| JK 164 / 42-3 TLT-3 ACJK 164 / 42-3 TLT-3 | Planet Fitness 42/3 TLT by Ergoline |
| Ergoline Vitality Total Light 3 | |
| JK 164 / 42-3 TLT ACJK 164 / 42-3 TLT | Planet Fitness 42/3 TLT by Ergoline |
| Ergoline Vitality Total Light 3 |
1.2.1 Device Description:
Total Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Using traditional UV light with the combination of red and blue light the user indulges in a new luxurious tanning experience.
Optimal tanning results are achieved due to the synergistic combination of light spectra.
1.2.2 Legally marketed predicate device:
| Device Name: | Planet Fitness 42/4 Hybrid Light Technology |
|---|---|
| 510k number: | K190173 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
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Legally marketed technical referenced device:
Sunrise 7200 Hybrid Light Technology Device Name: 510k number: K183539 Device Classification Name: Booth, Sun Tan Product Code: LEJ C.F.R. Section.: 878.4635 General & Plastic Surgery Classification Panel: Device Class: Class II
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1.2.3 Comparison bundle 1 to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate, the proposed and the technically referenced device.
| Parameter | Proposed device | Proposed device | Predicate device 1 | Technicallyreferenceddevice | Evaluation topredicate device | Evaluation toTechnicallyreferenceddevice | |
|---|---|---|---|---|---|---|---|
| Model-No. | JK 164 / 42-3 TLT-3 ACJK 164 / 42-3 TLT-3 | JK 164 / 42-3 TLTACJK 164 / 42-3 TLT | JK 126 / 42-4 HT AC | JK 158 / 48-0HT | N/A | N/A | |
| Intended Use | This sunlampproduct is intendedexclusively foraesthetic tanning ofthe human skin, forone person at atime, at the age of18 or above | This sunlampproduct is intendedexclusively foraesthetic tanning ofthe human skin, forone person at atime, at the age of18 or above | This sunlamp productis intendedexclusively foraesthetic tanning ofthe human skin, forone person at a time,at the age of 18 orabove | N/A | Identical | N/A | |
| Number of bodylamps | 42 (28 UV lampsand 14 UV + RedLight lamps) | 42 (28 UV lampsand 14 UV + RedLight lamps) | 42 (28 UV lamps and14 UV + Red Lightlamps) | N/A | Identical | N/A | |
| Watts of bodylamps | 200W | 160W | canopy 160Wbench 180W | N/A | Similar, the irradiancecharacteristics are stillcomparable asprovided under section18. The safety hasbeen confirmedadditionally bycorresponding tests inaccordance with IEC62471.In terms of functionalityand safety there is noimpact due to thisdifference. | N/A | |
| Parameter | Proposed device | Proposed device | Predicate device 1 | Technicallyreferenceddevice | Evaluation topredicate device | Evaluation toTechnicallyreferenceddevice | |
| Lamp itemdescription | GENESIS PLTPure LightTechnology 200WGENESIS HLTHybrid LightTechnology 200W(UV&Red light) | GENESIS PLTPure LightTechnology 160WGENESIS HLTHybrid LightTechnology 160W(UV&Red light) | GENESIS Type UHybrid Performance160 W / 180WGENESIS Type RHybrid Performance160W / 180W | N/A | Different description,no impact, see above. | N/A | |
| Number of TotalLight-LED | 72 LED (36 Red +36 Blue) | 36 LED (18 RED +18 Blue) | N/A | 60 Red LED | N/A | Similar, theirradiancecharacteristicsare stillcomparable asprovided undersection 18. Thesafety has beenconfirmedadditionally bycorrespondingtests inaccordance withIEC 62471.In terms offunctionality andsafety there isno impact due tothis difference. | |
| Watts of TotalLight-LED | 100W | 50W | N/A | 45W | N/A | No impact, seeabove. | |
| Parameter | Proposed device | Proposed device | Predicate device 1 | Technicallyreferenceddevice | Evaluation topredicate device | Evaluation toTechnicallyreferenceddevice | |
| UV-Facials | Number ofUV-facials | 3 x 42 UVA-LED | 3 x 42 UVA-LED | 4 high pressurelamps | N/A | Similar, the irradiancecharacteristics are stillcomparable asprovided under section18.In terms of functionalityand safety there is noimpact due to thisdifference. | N/A |
| Wattsfacial lamp | 3 x 80W | 3 x 80W | 4x400W | N/A | No impact, see below. | N/A | |
| Facial itemdescription | Spectra UV-LED | Spectra UV-LED | High pressure lampErgoline Ultra 520W | N/A | Similar, the irradiancecharacteristics are stillcomparable asprovided under section18.In terms of functionalityand safety there is noimpact due to thisdifference. | N/A | |
| Filter faciallamps | N/A | N/A | Ultra Performance862H | N/A | No filters necessarydue to no use of high-pressure lamps. | N/A | |
| Number oflowpressurefaciallamps | 2 x HLT | 2 x HLT | 3 x Type R | N/A | Similar, the irradiancecharacteristics are stillcomparable asprovided under section18. The safety hasbeen confirmedadditionally bycorresponding tests inaccordance with IEC62471.In terms of functionalityand safety there is noimpact due to thisdifference. | N/A | |
| Parameter | Proposed device | Proposed device | Predicate device 1 | Technicallyreferenceddevice | Evaluation topredicate device | Evaluation toTechnicallyreferenceddevice | |
| Watts lowpressurefacial lamp | 8W | 8W | 8W | N/A | Identical | N/A | |
| Lowpressurefaciallamps itemdescription | GENESIS HLTHybrid LightTechnology 8W | GENESIS HLTHybrid LightTechnology 8W | Genesis Type RHybrid 8W (Mix ofUV+Red Light) | N/A | Different description,no impact, see above. | N/A | |
| Max exposuretime [min] | 12 minutes | 12 minutes | 12 minutes | N/A | Identical | N/A | |
| ElectricalRequirements | 230V 3Ø or 230V2Ø | 230V 3Ø or 230V2Ø | 230V 3Ø or 230V 2Ø | N/A | Identical | N/A | |
| Total powerconsumption[watts] | 11,600 W (with AC)10,400 (w/o AC) | 8,800 W (with AC)7,200 W (w/o AC) | 11,200 W | N/A | Similar:The power isdifferent due todifferent lamps.Performance is notimpaired. | N/A | |
| Ratedovercurrentprotectiondevice (circuitbreaker) | 45A / 3-pole or 80A /2-pole (with AC)or45A / 3-pole or 70A/2-pole (w/o AC) | 35 A / 3-pole or 60A / 2-pole (with AC)30A / 3-pole or50A/ 2-pole (w/oAC) | 70A / 3-pole 3Ø or100A / 2-pole 2Ø | N/A | Similar, theovercurrent protectionis less with theproposed device dueto the use of LEDtechnology for facialsand different lamps.The irradianceCharacteristics are stillcomparable asprovided under section18. | N/A | |
| Number ofwires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | N/A | Identical | N/A | |
| Irradiance ratioin accordancewith 1040.20 | fulfilled | fulfilled | fulfilled | N/A | Identical (refer tosection 18 for benchtest reports) | N/A | |
| Parameter | Proposed device | Proposed device | Predicate device 1 | Technicallyreferenceddevice | Evaluation topredicate device | Evaluation toTechnicallyreferenced | |
| device | |||||||
| Electrical safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | N/A | Identical | N/A | |
| Electromagnetic compatibility | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | N/A | Identical | N/A |
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1.2.4 Summary of performance testing:
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20.
1.2.5 Conclusion:
JK-Holding GmbH believes that the JK 164 / 42-3 Total Light Technology are substantially equivalent to currently legally marketed devices. Also, all special controls are fulfilled. These devices do not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
1.3 Device trade names of bundle 2:
Planet Fitness 42/3 PLT by Ergoline Ergoline Vitality Pure Light
Common name: Sunlamp product
The following table presents the different variants of the JK 164 / 42-3 Pure Light Technology sunlamp product.
All variants use the same basic device technology and differ only in private labelling, exterior design, decor lighting and comfort features.
| Model-No. | Variant Name |
|---|---|
| JK 164 / 42-3 PLT AC | Planet Fitness 42/3 PLT by Ergoline |
| JK 164 / 42-3 PLT | Ergoline Vitality Pure Light |
1.3.1 Device description:
Pure Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation (UV lamps) and a mechanical structure.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.
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1.3.2 Legally marketed predicate device 2:
| Device Name: | Planet Fitness 42/4 |
|---|---|
| 510k number: | K151400 CV344_PF_100003421_V01 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
Device Class:
Class II
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1.3.3 Comparison bundle 2 to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate and the proposed device.
| Parameter | Proposed device | Predicate device | Evaluation to predicate device | |
|---|---|---|---|---|
| Model-No. | JK 164 / 42-3 PLT ACJK 164 / 42-3 PLT | JK 126 / 42-4 | N/A | |
| Intended Use | This sunlamp product is intendedexclusively for aesthetic tanning ofthe human skin, for one person at atime, at the age of 18 or above | This sunlamp product is intendedexclusively for aesthetic tanning ofthe human skin, for one person at atime, at the age of 18 or above | Identical | |
| Number of body lamps | 42 UV lamps | 42 UV lamps | Identical | |
| Watts of body lamps | 160W | 200 W | Similar, the irradiance characteristicsare still comparable as providedunder section 18.In terms of functionality and safetythere is no impact due to thisdifference. | |
| Lamp item description | GENESIS PLT Pure LightTechnology 160W | GENESIS VHP12Dynamic Power 200W | Different description, no impact, seeabove. | |
| UV-Facials | Number of UV-facials | 3 x 42 UVA-LED | 4 high pressure lamps | Similar, the irradiance characteristicsare still comparable as providedunder section 18.In terms of functionality and safetythere is no impact due to thisdifference. |
| Watts facial lamp | 3 x 80W | 4 x 400W | No impact, see below. | |
| Facial item description | Spectra UV-LED | High pressure lampErgoline Ultra 520W | Similar, the irradiance characteristicsare still comparable as providedunder section 18.In terms of functionality and safetythere is no impact due to thisdifference. | |
| Parameter | Proposed device | Predicate device | Evaluation to predicate device | |
| UV-Facials | Filter facial lamps | N/A | Ultra Performance 862 | No filters necessary due to no use ofhigh-pressure lamps. |
| Number of low pressurefacial lamps | 2 x PLT | 3 x Type U | Similar, the irradiance characteristicsare still comparable as providedunder section 18.In terms of functionality and safetythere is no impact due to thisdifference. | |
| Watts low pressure faciallamp | 8W | 8W | Identical | |
| Low pressure facial lampsitem description | GENESIS PLT Pure LightTechnology 8W | Genesis VHP B-Power E9 8W | Different description, no impact, seeabove. | |
| Max exposure time [min] | 12 minutes | 12 minutes | Identical | |
| Electrical Requirements | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | Identical | |
| Total power consumption [watts] | 9,000 W (with AC)7,800 W (w/o AC) | 13,200W | Similar, the total power consumptionis less with the proposed device dueto the use of LED technology forfacials and different lamps. Theirradiance characteristics are stillcomparable as provided undersection 18. | |
| Rated overcurrent protectiondevice (circuit breaker) | 35 A / 3-pole or 60 A / 2-pole (withAC)30A / 3-pole or 50A/ 2-pole (w/oAC) | 70A / 3-pole 3Ø or 100A / 2-pole 2Ø | Similar, die overcurrent protection isless with the proposed device due tothe use of LED technology for facialsand different lamps. The irradiancecharacteristics are still comparableas provided under section 18. | |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | Identical | |
| Irradiance ratio in accordancewith 1040.20 | fulfilled | fulfilled | Identical (refer to section 18 forbench test reports) | |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | Identical | |
| Electromagnetic compatibility | IEC 60601-1-2 | IEC 60601-1-2 | Identical |
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1.3.4 Summary of performance testing:
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20.
1.3.5 Conclusion:
JK-Holding GmbH believes that the JK 164 / 42-3 Pure Light Technology are substantially equivalent to currently legally marketed devices. Also, all special controls are fulfilled. These devices do not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
1.4 Device trade names of bundle 3:
Planet Fitness 50/4 TLT by Ergoline Ergoline Vitality Total Light 3 Planet Fitness 50/4 HLT by Ergoline Ergoline Vitality Hybrid Light 3
Common name: Sunlamp product
The following table presents the different variants of the JK 164 / 50-4 Total Light Technology and JK 164 / 50-4 Hybrid Light Technology sunlamp product.
All variants use the same basic device technology and differ only in private labelling, exterior design, decor lighting, combination of light spectra and comfort features.
| Model-No. | Variant Name |
|---|---|
| JK 164 / 50-4 TLT-3 TT | Planet Fitness 50/4 TLT by Ergoline |
| JK 164 / 50-4 TLT-3 | Ergoline Vitality Total Light 3 |
| JK 164 / 50-4 HLT-3 TT | Planet Fitness 50/4 HLT by Ergoline |
| JK 164 / 50-4 HLT-3 | Ergoline Vitality Hybrid Light 3 |
| JK 164 / 50-4 TLT TT | Ergoline Vitality Total Light 3 |
| JK 164 / 50-4 TLT AC | Planet Fitness 50/4 TLT by Ergoline |
| JK 164 / 50-4 TLT | Ergoline Vitality Total Light 3 |
1.4.1 Device description:
Total Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface.
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UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Using traditional UV light with the combination of red and blue light the user indulges in a new luxurious tanning experience.
Optimal tanning results are achieved due to the synergistic combination of light spectra.
Hybrid Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results.
Traditional UV light with the addition of (beauty) red light results in a natural looking tan. Optimal tanning results are achieved due to the synergistic combination of light spectra.
1.4.2 Leqally marketed predicate device:
| Device Name: | Ergoline Prestige 1600 Hybrid Technology |
|---|---|
| 510k number: | K180555 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
Legally marketed technical referenced device:
| Device Name: | Sunrise 7200 Hybrid Light Technology |
|---|---|
| 510k number: | K183539 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
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1.4.3 Comparison bundle 3 to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate, the proposed and the technically referenced device.
| Parameter | Proposeddevice | Proposeddevice | Proposeddevice | Proposeddevice | Predicatedevice | Technicallyreferenceddevice | Evaluation topredicatedevice | Evaluation toTechnicallyreferenceddevice |
|---|---|---|---|---|---|---|---|---|
| Model-No. | JK 164 / 50-4TLT-3 TTJK 164 / 50-4TLT-3 | JK 164 / 50-4HLT-3 TTJK 164 / 50-4HLT-3 | JK 164 /50-4 TLTTT | JK 164 /50-4 TLTACJK 164 /50-4 TLT | JK 162 / 52-4 TT HP | JK 158 / 48-0 HT | N/A | N/A |
| Intended Use | This sunlampproduct isintendedexclusively foraesthetictanning of thehuman skin,for oneperson at atime, at theage of 18 orabove | This sunlampproduct isintendedexclusively foraesthetictanning of thehuman skin,for one personat a time, atthe age of 18or above | Thissunlampproduct isintendedexclusivelyforaesthetictanning ofthe humanskin, forone personat a time,at the ageof 18 orabove | Thissunlampproduct isintendedexclusivelyforaesthetictanning ofthe humanskin, forone personat a time,at the ageof 18 orabove | Thissunlampproduct isintendedexclusivelyfor aesthetictanning ofthe humanskin, for oneperson at atime, at theage of 18 orabove | N/A | Identical | N/A |
| Parameter | Proposeddevice | Proposeddevice | Proposeddevice | Proposeddevice | Predicatedevice | Technicallyreferenceddevice | Evaluation topredicatedevice | Evaluation toTechnicallyreferenceddevice |
| Number of bodylamps | 50 (36 UVlamps + 14UV+Red Lightlamps) | 50 (36 UVlamps + 14UV+Red Lightlamps) | 50 (36 UVlamps + 14UV+RedLightlamps) | 50 (36 UVlamps + 14UV+RedLightlamps) | 52 (38 UVlamps and14 UV+RedLight lamps) | N/A | Similar, theirradiancecharacteristicsare stillcomparableas providedunder section18. The safetyhas beenconfirmedadditionally bycorrespondingtests inaccordancewith IEC62471.In terms offunctionalityand safetythere is noimpact due tothisdifference. | N/A |
| Watts of bodylamps | 200W | 200W | 160W | 160W | 200 W | N/A | Identical | N/A |
| Lamp itemdescription | GENESISPLT PureLightTechnology200WGENESISHLT HybridLightTechnology200W(UV&Redlight) | GENESIS PLTPure LightTechnology200WGENESISHLT HybridLightTechnology200W(UV&Redlight) | GENESISPLT PureLightTechnology160WGENESISHLT HybridLightTechnology160W(UV&Redlight) | GENESISPLT PureLightTechnology | GENESISType UHybridPerformanceGENESISType RHybridPerformance(UV & Redlight) | N/A | Differentdescription,no impact,see above. | N/A |
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| Parameter | Proposed device | Proposed device | Proposed device | Proposed device | Predicate device | Technically referenced device | Evaluation to predicate device | Evaluation to Technically referenced device | |
|---|---|---|---|---|---|---|---|---|---|
| Number of Total Light-LED | 108 LED (54 Red + 54 Blue) | 90 Red LED | 36 LED (18 RED + 18 Blue) | 36 LED (18 RED + 18 Blue) | N/A | 60 Red LED | N/A | Similar, the irradiance characteristics are still comparable as provided under section 18. The safety has been confirmed additionally by corresponding tests in accordance with IEC 62471. In terms of functionality and safety there is no impact due to this difference. | |
| Watts of Total Light-LED | 150W | 120W | 50W | 50W | N/A | 45W | N/A | No impact, see below. | |
| Parameter | Proposed device | Proposed device | Proposed device | Proposed device | Predicate device | Technically referenced device | Evaluation to predicate device | Evaluation to Technically referenced device | |
| UV-Facials | Number of UV-facials | 4 x 42 UVA-LED | 4 x 42 UVA-LED | 4 x 42 UVA-LED | 4 x 42 UVA-LED | 4 high pressure lamps | N/A | Similar, the irradiance characteristics are still comparable as provided under section 18. In terms of functionality and safety there is no impact due to this difference. | N/A |
| Watts facial lamp | 4 x 80W | 4 x 80W | 4 x 80W | 4 x 80W | 4 x 520 W | N/A | No impact, see below. | N/A | |
| Facial item description | Spectra UV-LED | Spectra UV-LED | Spectra UV-LED | Spectra UV-LED | High pressure lamp Ergoline Ultra 520W | N/A | Similar, the irradiance characteristics are still comparable as provided under section 18. In terms of functionality and safety there is no impact due to this difference. | N/A | |
| Filter facial lamps | N/A | N/A | N/A | N/A | Ultra Performance 412 | N/A | No filters necessary due to no use of high pressure lamps. | N/A | |
| Parameter | Proposeddevice | Proposeddevice | Proposeddevice | Proposeddevice | Predicatedevice | Technicallyreferenceddevice | Evaluation topredicatedevice | Evaluation toTechnicallyreferenceddevice | |
| UV-Facials | Number oflowpressurefaciallamps | 4 x HLT | 4 x HLT | 4 x HLT | 4 x HLT | 3 x Type R | N/A | Similar, theirradiancecharacteristicsare stillcomparable asprovided undersection 18. Thesafety has beenconfirmedadditionally bycorrespondingtests inaccordancewith IEC 62471.In terms offunctionalityand safetythere is noimpact due tothis difference. | N/A |
| Watts lowpressurefacial lamp | 8W | 8W | 8W | 8W | 8 W | N/A | Identical | N/A | |
| Lowpressurefaciallamps itemdescription | GENESISHLT HybridLightTechnology8W | GENESISHLT HybridLightTechnology8W | GENESISHLT HybridLightTechnology8W | GENESISHLT HybridLightTechnology8W | GenesisType RHybrid 8W | N/A | Differentdescription, noimpact, seeabove. | N/A | |
| Parameter | Proposeddevice | Proposeddevice | Proposeddevice | Proposeddevice | Proposeddevice | Predicatedevice | Technicallyreferenceddevice | Evaluation topredicatedevice | EvaluationtoTechnicallyreferenceddevice |
| Shoulder Tanner | Number ofShoulderlamps | 2 x 20 UVA-LED | 2 x 20 UVA-LED | 2 x 20UVA-LED | 2 x 20UVA-LED | 2 highpressurelamps | N/A | Similar, theirradiancecharacteristicsare stillcomparable asprovided undersection 18.In terms offunctionality andsafety there isno impact due tothis difference. | N/A |
| Watts ofshoulderlamps | 2 x 40W | 2 x 40W | 2 x 40W | 2 x 40W | 240W | N/A | No impact, seebelow. | N/A | |
| Lamp itemdescriptionshoulderlamps | Spectra UV-LED | Spectra UV-LED | SpectraUV-LED | SpectraUV-LED | ErgolineUltra 250W | N/A | Similar, theirradiancecharacteristicsare stillcomparable asprovided undersection 18.In terms offunctionality andsafety there isno impact due tothis difference. | N/A | |
| Filtershoulderlamps | N/A | N/A | N/A | N/A | UltraPerformance912 | N/A | No filtersnecessary dueto no use ofhigh pressurelamps. | N/A | |
| Parameter | Proposeddevice | Proposeddevice | Proposeddevice | Proposeddevice | Predicatedevice | Technicallyreferenceddevice | Evaluation topredicatedevice | EvaluationtoTechnicallyreferenceddevice | |
| Max exposure time[min] | 10 minutes | 10 minutes | 10 minutes | 10minutes | 10 minutes | N/A | Identical | N/A | |
| ElectricalRequirements | 230V 3Ø or230V 2Ø | 230V 3Ø or230V 2Ø | 230V 3Ø or230V 2Ø | 230V 3Øor 230V2Ø | 230V 3Ø or230V 2Ø | N/A | Identical | N/A | |
| Total powerconsumption[watts] | 14,600 W (wTT)12,200 W(w/o TT) | 14,600 W (wTT)12,200 W (w/oTT) | 11,400 W(w TT) | 10,200 W(with AC)9,000 W(w/o AC) | 17,600W | N/A | Similar, thetotal powerconsumption isless with theproposeddevice due tothe use of LEDtechnology forfacials and lesslamps. Theirradiancecharacteristicsare stillcomparable asprovidedunder section18. | N/A | |
| Parameter | Proposeddevice | Proposeddevice | Proposeddevice | Proposeddevice | Predicatedevice | Technicallyreferenceddevice | Evaluation topredicatedevice | EvaluationtoTechnicallyreferenceddevice | |
| Rated overcurrentprotection device(circuit breaker) | 60A / 3-poleor 90 A /2-pole (withTT) or50A / 3-poleor 80 A/2-pole (w/o TT) | 60A / 3-pole or90A /2-pole(with TT) or50A / 3-pole or80A /2-pole(w/o TT) | 40A /3-poleor 70A / 2-pole (withTT) | 40A /3-pole or 70A/2-pole(with AC)or40A / 3-pole or 60A/ 2-pole(w/o AC) | 70A / 3-pole3Ø or 100A /2-pole 2Ø | N/A | Similar, dieovercurrentprotection isless with theproposeddevice due tothe use of LEDtechnology forfacials and lesslamps. Theirradiancecharacteristicsare stillcomparable asprovidedunder section18. | N/A | |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | N/A | Identical | N/A | |
| Irradiance ratio inaccordance with1040.20 | fulfilled | fulfilled | fulfilled | fulfilled | fulfilled | N/A | Identical (referto section 18 forbench testreports) | N/A | |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | N/A | Identical | N/A | |
| Electromagneticcompatibility | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | N/A | Identical | N/A |
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{29}------------------------------------------------
1.4.4 Summary of performance testing:
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20.
1.4.5 Conclusion:
JK-Holding GmbH believes that the JK 164 / 50-4 Total Light Technology and JK 164 / 50-4 Hybrid Light Technology are substantially equivalent to currently legally marketed devices. Also, all special controls are fulfilled. These devices do not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
1.5 Device trade names of bundle 4:
Planet Fitness 50/4 PLT III by Ergoline Ergoline Vitality Pure Light 3 Planet Fitness 50/4 PLT by Ergoline Ergoline Vitality Pure Light
Sunlamp product Common name:
The following table presents the different variants of the JK 164 / 50-4 Pure Light Technology sunlamp product.
All variants use the same basic device technology and differ only private labelling, exterior design, decor lighting and comfort features.
| Model-No. | Variant Name |
|---|---|
| JK 164 / 50-4 PLT-3 AC | Planet Fitness 50/4 PLT III by Ergoline |
| JK 164 / 50-4 PLT-3 | Ergoline Vitality Pure Light 3 |
| JK 164 / 50-4 PLT AC | Planet Fitness 50/4 PLT by Ergoline |
| JK 164 / 50-4 PLT | Ergoline Vitality Pure Light |
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1.5.1 Device description:
Pure Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation (UV lamps) and a mechanical structure.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.
1.5.2 Legally marketed predicate device 4:
| Device Name: | Affinity 900 AP TT AM/A USA |
|---|---|
| 510k number: | K151400 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
{31}------------------------------------------------
1.5.3 Comparison bundle 4 to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate and the proposed device.
| Parameter | Proposed device | Proposed device | Predicate device | Evaluation to predicate device | |
|---|---|---|---|---|---|
| Model-No. | JK 164 / 50-4 PLT-3 ACJK 164 / 50-4 PLT-3 | JK 164 / 50-4 PLT ACJK 164 / 50-4 PLT | JK 155 / 50-4 TT | N/A | |
| Intended Use | This sunlamp product isintended exclusively foraesthetic tanning of thehuman skin, for oneperson at a time, at theage of 18 or above | This sunlamp product isintended exclusively foraesthetic tanning of thehuman skin, for oneperson at a time, at theage of 18 or above | This sunlamp product isintended exclusively foraesthetic tanning of thehuman skin, for oneperson at a time, at theage of 18 or above | Identical | |
| Number of body lamps | 50 UV lamps | 50 UV lamps | 50 UV lamps | Identical | |
| Watts of body lamps | 200W | 160W | 160 W | Similar, the irradiancecharacteristics are stillcomparable as providedunder section 18.In terms of functionalityand safety there is noimpact due to thisdifference. | |
| Lamp item description | GENESIS PLT Pure LightTechnology 200W | GENESIS PLT Pure LightTechnology 160W | GENESIS VHP12 160W | Different description, noimpact, see above. | |
| UV-Facials | Number of UV-facials | 4 x 42 UVA-LED | 4 x 42 UVA-LED | 4 high pressure lamps | Similar, the irradiancecharacteristics are stillcomparable as providedunder section 18.In terms of functionalityand safety there is noimpact due to thisdifference. |
| Watts facial lamp | 4 x 80W | 4 x 80W | 4 x 520 W | No impact, see below. | |
| Parameter | Proposed device | Proposed device | Predicate device | Evaluation to predicatedevice | |
| UV-Facials | Facial itemdescription | Spectra UV-LED | Spectra UV-LED | High pressure lampErgoline Ultra 520W | Similar, the irradiancecharacteristics are stillcomparable as providedunder section 18.In terms of functionalityand safety there is noimpact due to thisdifference. |
| Filter facial lamps | N/A | N/A | Ultra Performance 412H | No filters necessary dueto no use of highpressure lamps. | |
| Number of lowpressure faciallamps | 4 x PLT | 4 x PLT | 3 x Type U | Similar, the irradiancecharacteristics are stillcomparable as providedunder section 18.In terms of functionalityand safety there is noimpact due to thisdifference. | |
| Watts lowpressure faciallamp | 8W | 8W | 8 W | Identical | |
| Low pressurefacial lamps itemdescription | GENESIS PLT Pure LightTechnology 8W | GENESIS PLT Pure LightTechnology 8W | GENESIS VHP12 8W | Different description, noimpact, see above. | |
| Shoulder Tanner | Number ofShoulder lamps | 2 x 20 UVA-LED | 2 x 20 UVA-LED | 7 low pressure lamps | Similar, the irradiancecharacteristics are stillcomparable as providedunder section 18.In terms of functionalityand safety there is noimpact due to thisdifference. |
| Watts of shoulderlamps | 2 x 40W | 2 x 40W | 7 x 25W | No impact, see below. | |
| Parameter | Proposed device | Proposed device | Predicate device | Evaluation to predicatedevice | |
| Shoulder Tanner | Lamp item descriptionshoulder lamps | Spectra UV-LED | Spectra UV-LED | GENESIS VHP12 25 W | Similar, the irradiancecharacteristics are stillcomparable as providedunder section 18.In terms of functionalityand safety there is noimpact due to thisdifference. |
| Filter shoulderlamps | N/A | N/A | N/A | No filters necessary dueto no use of highpressure lamps. | |
| Max exposure time [min] | 12 minutes | 12 minutes | 12 minutes | Identical | |
| Electrical Requirements | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | Identical | |
| Total power consumption[watts] | 13,400 W (w AC)12,200 W (w/o AC) | 10,600 W (w AC)9,400 W (w/o AC) | 17,000W | Similar, the total powerconsumption is less withthe proposed device dueto the use of LEDtechnology for facials. Theirradiance characteristicsare still comparable asprovided under section18. | |
| Rated overcurrentprotection device(circuit breaker) | 50A / 3-pole or 90 A /2-pole (with AC) or50A / 3-pole or 80 A /2-pole (w/o AC) | 40A / 3-pole or 70 A /2-pole (with AC) or40A / 3-pole or 60A /2-pole (w/o AC) | 60A / 3-pole 3Ø or 110A /2-pole 2Ø | Similar, die overcurrentprotection is less with theproposed device due tothe use of LEDtechnology for facials. Theirradiance characteristicsare still comparable asprovided under section18. | |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | Identical | |
| Irradiance ratio inaccordance with 1040.20 | fulfilled | fulfilled | fulfilled | Identical (refer to section18 for bench test reports) | |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Identical | |
| Electromagneticcompatibility | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Identical |
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1.5.4 Summary of performance testing:
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20.
1.5.5 Conclusion:
JK-Holding GmbH believes that the JK 164 / 50-4 Pure Light Technology are substantially equivalent to currently legally marketed devices. Also, all special controls are fulfilled. These devices do not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
1.6 Device trade names of bundle 5:
Planet Fitness 46/3 PLT by Ergoline Ergoline Vitality Pure Light Planet Fitness 46/3 HLT by Ergoline Ergoline Vitality Hybrid Light
Sunlamp product Common name:
The following table presents the different variants of the JK 164 / 46-3 Pure Light Technology and JK 164 / 46-3 Hybrid Light Technology sunlamp product.
All variants use the same basic device technology and differ only private labelling, exterior design, decor lighting, combination of light spectra and comfort features.
| Model-No. | Variant Name |
|---|---|
| JK 164 / 46-3 PLT ACJK 164 / 46-3 PLT | Planet Fitness 46/3 PLT by ErgolineErgoline Vitality Pure Light |
| JK 164 / 46-3 HLT ACJK 164 / 46-3 HLT | Planet Fitness 46/3 HLT by ErgolineErgoline Vitality Hybrid Light |
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1.6.1 Device Description:
Pure Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation (UV lamps) and a mechanical structure.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.
Hybrid Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Traditional UV light with the addition of (beauty) red light results in a natural looking tan. Optimal tanning results are achieved due to the synergistic combination of light spectra.
1.6.2 Legally marketed predicate device 5:
| Device Name: | Affinity 700 PF AP AC USA |
|---|---|
| 510k number: | K151400 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
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1.6.3 Comparison bundle 5 to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate and the proposed device.
| Parameter | Proposed device | Proposed device | Predicate device | Technicallyreferenceddevice | Evaluation topredicate device | Evaluation toTechnicallyreferenceddevice | |
|---|---|---|---|---|---|---|---|
| Model-No. | JK 164 / 46-3 PLTACJK 164 / 46-3 PLT | JK 164 / 46-3 HLTACJK 164 / 46-3 HLT | JK 155 / 46-3 | JK 158 / 48-0 HT | N/A | N/A | |
| Intended Use | This sunlampproduct is intendedexclusively foraesthetic tanning ofthe human skin, forone person at a time,at the age of 18 orabove | This sunlampproduct is intendedexclusively foraesthetic tanning ofthe human skin, forone person at atime, at the age of18 or above | This sunlampproduct is intendedexclusively foraesthetic tanning ofthe human skin, forone person at atime, at the age of18 or above | N/A | Identical | N/A | |
| Number of body lamps | 46 UV lamps | 46 UV lamps | 46 UV lamps | N/A | Identical | N/A | |
| Watts of body lamps | 160W | 160W | 160W | N/A | Identical | N/A | |
| Lamp item description | GENESIS PLT PureLight Technology160W | GENESIS PLTPure LightTechnology 160W | GENESIS VHP12160W | N/A | Different description,no impact, see above. | N/A | |
| Parameter | Proposed device | Proposed device | Predicate device | Technicallyreferenceddevice | Evaluation topredicate device | Evaluation toTechnicallyreferenceddevice | |
| Number of Total Light-LED | N/A | 72 Red LED | N/A | 60 Red LED | N/A | Similar, theirradiancecharacteristicsare stillcomparable asprovided undersection 18. Thesafety has beenconfirmedadditionally bycorrespondingtests inaccordance withIEC 62471.In terms offunctionality andsafety there isno impact due tothis difference. | |
| Watts of Total Light-LED | N/A | 95W | N/A | 45W | N/A | No impact, seebelow. | |
| UV-Facials | Number ofUV-facials | 3 x 42 UVA-LED | 3 x 42 UVA-LED | 3 high pressurelamps | N/A | Similar, the irradiancecharacteristics are stillcomparable asprovided under section18.In terms offunctionality andsafety there is noimpact due to thisdifference. | N/A |
| Watts faciallamp | 3 x 80W | 3 x 80W | 3 x 500W | N/A | No impact, see below. | N/A | |
| Parameter | Proposed device | Proposed device | Predicate device | Technicallyreferenceddevice | Evaluation topredicate device | Evaluation toTechnicallyreferenceddevice | |
| UV-Facials | Facial itemdescription | Spectra UV-LED | Spectra UV-LED | High pressure lampErgoline Ultra520W | N/A | Similar, the irradiancecharacteristics are stillcomparable asprovided under section18.In terms offunctionality andsafety there is noimpact due to thisdifference. | N/A |
| Filter faciallamps | N/A | N/A | Ultra Performance412 H | N/A | No filters necessarydue to no use of highpressure lamps. | N/A | |
| Number of lowpressure faciallamps | 2x PLT | 2x HLT | 2 x Type U | N/A | Similar, the irradiancecharacteristics are stillcomparable asprovided under section18. The safety hasbeen confirmedadditionally bycorresponding tests inaccordance with IEC62471.In terms offunctionality andsafety there is noimpact due to thisdifference. | N/A | |
| Watts lowpressure faciallamp | 8W | 8W | 8W | N/A | Identical | N/A | |
| Low pressurefacial lampsitemdescription | GENESIS PLT PureLight Technology 8W | GENESIS HLTHybrid LightTechnology 8W | GENESIS VHP128W | N/A | Different description,no impact, see above. | N/A | |
| Parameter | Proposed device | Proposed device | Predicate device | Technicallyreferenceddevice | Evaluation topredicate device | Evaluation toTechnicallyreferenceddevice | |
| Shoulder Tanner | Number ofShoulderlamps | 2 x 20 UVA-LED | 2 x 20 UVA-LED | 7 low pressurelamps | N/A | Similar, the irradiancecharacteristics are stillcomparable asprovided under section18.In terms offunctionality andsafety there is noimpact due to thisdifference. | N/A |
| Watts ofshoulderlamps | 2 x 40W | 2 x 40W | 7 x 25W | N/A | No impact, see below. | N/A | |
| Lamp itemdescriptionshoulderlamps | Spectra UV-LED | Spectra UV-LED | GENESIS VHP1225 W | N/A | Similar, the irradiancecharacteristics are stillcomparable asprovided under section18.In terms offunctionality andsafety there is noimpact due to thisdifference. | N/A | |
| Filter shoulderlamps | N/A | N/A | N/A | N/A | No filters necessarydue to no use of highpressure lamps. | N/A | |
| Max exposure time[min] | 12 minutes | 12 minutes | 12 minutes | N/A | Identical | N/A | |
| ElectricalRequirements | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V2Ø | 230V 3Ø or 230V2Ø | N/A | Identical | N/A | |
| Parameter | Proposed device | Proposed device | Predicate device | Technicallyreferenceddevice | Evaluation topredicate device | Evaluation toTechnicallyreferenceddevice | |
| Total powerconsumption [watts] | 9,600 W (with AC)8,400 W (w/o AC) | 9,600 W (withAC)8,400 W (w/o AC) | 13,700W | N/A | Similar, the totalpower consumptionis less with the pro-posed device due tothe use of LED tech-nology for facials.The irradiance cha-racteristics are stillcomparable asprovided undersection 18. | N/A | |
| Rated overcurrentprotection device(circuit breaker) | 40A / 3-pole or 60A/ 2-pole (with AC)or35A /3-pole or 60A/ 2-pole (w/o AC) | 40A / 3-pole or60A / 2-pole (withAC) or35A /3-pole or60A / 2-pole (w/oAC) | 50A / 3-pole 3Ø or80A / 2-pole 2Ø | N/A | Similar, die overcur-rent protection isless with the propo-sed device due tothe use of LED tech-nology for facials.The irradiancecharacteristics arestill comparable asprovided undersection 18. | N/A | |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | N/A | Identical | N/A | |
| Irradiance ratio inaccordance with1040.20 | fulfilled | fulfilled | fulfilled | N/A | Identical (refer tosection 18 for benchtest reports) | N/A | |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | N/A | Identical | N/A | |
| Electromagneticcompatibility | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | N/A | Identical | N/A |
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1.6.4 Summary of performance testing:
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20.
1.6.5 Conclusion:
JK-Holding GmbH believes that the JK 164 / 46-3 Pure Light Technology and JK 164 / 46-3 Hybrid Light Technology are substantially equivalent to currently legally marketed devices. Also, all special controls are fulfilled. These devices do not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
§ 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a)
Identification. A sunlamp product is any device designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. This definition includes tanning beds and tanning booths. A UV lamp intended for use in sunlamp products is any lamp that produces UV radiation in the wavelength interval of 200 to 400 nanometers in air.(b)
Classification. Class II (special controls). The special controls for sunlamp products and UV lamps intended for use in sunlamp products are:(1) Conduct performance testing that demonstrates the following:
(i) Device meets appropriate output performance specifications such as wavelengths, energy density, and lamp life; and
(ii) Device's safety features, such as timers to limit UV exposure and alarms, function properly.
(2) Demonstrate that device is mechanically safe to prevent user injury.
(3) Demonstrate software verification, validation, and hazard analysis.
(4) Demonstrate that device is biocompatible.
(5) Demonstrate that device is electrically safe and electromagnetically compatible in its intended use environment.
(6)
Labeling —(i)Sunlamp products. (A) The warning statement below must appear on all sunlamp products and must be placed in a black box. This statement must be permanently affixed or inscribed on the product when fully assembled for use so as to be legible and readily accessible to view by the person who will be exposed to UV radiation immediately before the use of the product. It shall be of sufficient durability to remain legible throughout the expected lifetime of the product. It shall appear on a part or panel displayed prominently under normal conditions of use so that it is readily accessible to view whether the tanning bed canopy (or tanning booth door) is open or closed when the person who will be exposed approaches the equipment and the text shall be at least 10 millimeters (height). Labeling on the device must include the following statement: Attention: This sunlamp product should not be used on persons under the age of 18 years. (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions.
(ii)
Sunlamp products and UV lamps intended for use in sunlamp products. Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements:(A) “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
(B) “Contraindication: This product must not be used if skin lesions or open wounds are present.”
(C) “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
(D) “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
(c)
Performance standard. Sunlamp products and UV lamps intended for use in sunlamp products are subject to the electronic product performance standard at § 1040.20 of this chapter.