(91 days)
Not Found
Not Found
No
The device description details a simple ultraviolet lamp technology based on mercury-rare gas discharge, similar to fluorescent lamps. There is no mention of any computational processing, algorithms, or learning capabilities. The performance testing focuses on electrical, mechanical, dimensional, and UV radiation characteristics, not on any AI/ML-driven performance metrics.
No
The intended use of the device is for tanning of human skin, which is a cosmetic purpose, not for treating or diagnosing a disease or condition. While it is a medical device, it is not a therapeutic one.
No
Explanation: The device is a sunlamp intended for tanning human skin, which is a cosmetic purpose, not a diagnostic one. Its function is to emit UV radiation for skin tanning, not to identify or monitor medical conditions.
No
The device description clearly details the physical components of a sunlamp, including a glass envelope, phosphor coating, electrodes, and mercury. It describes the electrical and physical principles of operation, indicating it is a hardware device that emits UV radiation. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in sunlamp products for tanning of the human skin." This is a direct application to the human body for a cosmetic/physiological effect (tanning), not for testing samples taken from the body (in vitro).
- Device Description: The description details the physical construction and operation of a lamp that emits ultraviolet radiation. This is consistent with a device that interacts with the external surface of the body, not with biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly described as a sunlamp intended for tanning, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
INTENDED USE: Wolff System sunlamps are intended for use in sunlamp products for tanning of the human skin.
Product codes (comma separated list FDA assigned to the subject device)
LEJ
Device Description
This 510(k) applies to more than one hundred and eighty individual devices that fall into a generic class of ultraviolet lamps that have the same basic technological features and exactly the same intended use. The ultraviolet sunlamps of this 510(k) are classified scientifically as low pressure, mercuryrare gas discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the same as that of a common fluorescent lamp. The main differentiators for the various sunlamps of this 510(k) include: lamp length, lamp diameter, lamp wattage, spectral characteristics and private labeling thereof.
The ultraviolet lamps named herein comprise a tubular glass envelope, the internal surface of which is coated with a fluorescent phosphor. To each end of the tube, a glass mount is sealed. The main purpose of the mount is to provide 1) for a means of hermetically sealing the internal atmosphere of the tube, 2) a means of supporting an electrode and a means of 3) electrically accessing the internal atmosphere of the device via electrically conducting lead-wires. Once assembled as described, the envelope is evacuated of air, the air is replaced by an inert gas at a pressure significantly lower than that of the normal atmosphere, and a drop of mercury is injected into the enclosed envelope. Finally, the envelope is sealed.
In operation, the device, now called a "lamp", is connected to an electrical source typically in series with a ballast that provides for 1) ignition of a discharge through the inert-gas-mercury vapor mixture and 2) its subsequent stabilization and sustainment of the electrical behavior of the lamp. Once connected to the applied electric field, free electrons are accelerated through the mercury vapor wherein collisions take place with the mercury atoms. These collisions cause excitation of the electrons in the mercury (Hg) atom and the production of photons at various wavelengths. Certain of these photons travel to the bulb wall and excite the phosphor powder. The phosphor, in turn, emits radiation that is transmitted through the transparent glass envelope. The radiation that is emitted from a standard fluorescent general lighting lamp is primarily in the visible region of the spectrum (380nm-760nm). The radiation that is emitted from an ultraviolet sunlamp is primarily in the UV range of the electromagnetic spectrum (300nm-400nm). Modern day, low pressure ultraviolet sunlamps typically emit most of their energy in the wavelength range that is closest to the visible; that is, in the UVA range (320nm-400nm) range. The emission spectrum of sunlamps usually contains a relatively small proportion of UVB radiation. (260nm-320nm)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All lamps are 100% tested for functionality at the end of the manufacturing process. Lamps that do not meet critical characteristics for functionality and safety are rejected.
According to a Quality Sampling Plan, lamps are tested in-process and / or post-production for:
- Electrical Characteristics and Safety
- Mechanical Safety
- Dimensional Integrity
- Physical Design Attributes
- UV radiation Characteristics, including:
- UVA Irradiance
- Erythemal Effective Irradiance
- UVC/UVB ratio per 21 CFR 1040.20
Lamps that do not meet Acceptance Criteria are either re-worked, if technically feasible, or scrapped.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4635 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.
0
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the silhouettes of the human faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wolff System Technology Corporation % Mr. Steven Schlitt Cosmedico Light Incorporated 233 Libbey Industrial Parkway Weymouth, Massachusetts 01860
October 5, 2015
Re: K151841 Trade/Device Name: Wolff System Sunlams 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: July 2, 2015 Received: July 8, 2015
Dear Mr. Schlitt:
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); medical device reporting (reporting of medical device-related adverse events) (21 CFR
1
803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/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,
Joshua
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151841
Device Name
Wolff System Sunlamps Intended for Use in Sunlamp Products (commonly referred to as "Ultraviolet Sunlamps")
Indications for Use (Describe)
INTENDED USE: Wolff System sunlamps are intended for use in sunlamp products for tanning of the human skin.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary Per Sec. 807.92(c)
807.92(a)(1)
APPLICANT
| Date Prepared: | July 2, 2015 / REVISED: Oct. 1, 2015 |
|---|---|
| 510(k) Company / Holder Name: | Wolff System Technology Corporation |
| Applicant Contact Name: | Michael Stepp |
| Applicant Title: | President |
| Applicant Address: | 980 Cobb Place Blvd N.W. Suite 200 |
| Kennesaw, GA 30144 | |
| Applicant Phone Number: | 678-355-1400 (Ext. 114) |
| Applicant Fax Number: | 678-355-1475 |
CONSULTANT / PREPARER
| Contact Name: | Steven Schlitt |
|---|---|
| Title: | Dir. of Engineering & Quality |
| Address: | 233 Libbey Industrial Pkwy |
| Weymouth, MA 02189 | |
| Phone Number: | 781-331-0949 (Ext. 107) |
| Fax Number: | 781-331-4766 |
4
| Device Proprietary Name: | Wolff System Sunlamps
See various brands in Attachment F-1 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Device Common or Usual Name: | Ultraviolet Sunlamps |
| Indication for Use / Intended Use | INTENDED USE: Wolff System sunlamps are
intended for use in sunlamp products for
tanning of the human skin. |
| Classification Name: | Sunlamp products and ultraviolet lamps intended for
use in sunlamp products (21 CFR 478.4635) |
| Classification Code: | LEJ |
| Regulation Number: | 21 CFR Part 878.4635 |
| Device Classification | II |
807.92(a)(3)
Predicate Devices:
Prior to September 2, 2014, the basic ultraviolet sunlamps named in this 510(k) existed and were offered for sale as legally marketed, Class I, 510(k) exempt, medical devices.
For the basis of this 510(k), Wolff System claims substantial equivalence to these legally marketed devices. Since none of the ultraviolet lamps named in this 510(k) have changed in 1) intended use or 2) technological design characteristics after September 2, 2014, essentially the contemporary ultraviolet lamps are identical to the predicate devices (i.e., those basic sunlamps offered for sale prior to the FDA's cutoff date of Sept. 2, 2014).
Such an approach of using the legally marketed Class I medical devices as predicate devices is validated in the Final Reclassification Order published on June 2, 2014 in the Federal Register Vo. 79, No. 105, Page 31212 whereby it is stated that:
" FDA cleared several 510(k)s for sunlamp products prior to exempting the devices from premarket notification submission. At least one 510(k) for a sunlamp product has been cleared since then under product code LEJ.
5
These cleared sunlamp products. as well as any 510(k)-exempt sunlamp product or UV lamp intended for use in a sunlamp product legally offered for sale on or before September 2, 2014, can serve as predicates for substantial equivalence purposes."
lt will be demonstrated in this 510(k) that the named ultraviolet lamps:
-
- have the same intended use as the predicate devices
-
- have the same technological characteristics as the predicate devices and
-
- conform to the special controls required by the reclassification order
In short, the contemporary ultraviolet sunlamps of this 510(k) are as safe and as effective as the predicate devices.
Description of the Devices
This 510(k) applies to more than one hundred and eighty individual devices that fall into a generic class of ultraviolet lamps that have the same basic technological features and exactly the same intended use. The ultraviolet sunlamps of this 510(k) are classified scientifically as low pressure, mercuryrare gas discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the same as that of a common fluorescent lamp. The main differentiators for the various sunlamps of this 510(k) include: lamp length, lamp diameter, lamp wattage, spectral characteristics and private labeling thereof.
The ultraviolet lamps named herein comprise a tubular glass envelope, the internal surface of which is coated with a fluorescent phosphor. To each end of the tube, a glass mount is sealed. The main purpose of the mount is to provide 1) for a means of hermetically sealing the internal atmosphere of the tube, 2) a means of supporting an electrode and a means of 3) electrically accessing the internal atmosphere of the device via electrically conducting lead-wires. Once assembled as described, the envelope is evacuated of air, the air is replaced by an inert gas at a pressure significantly lower than that of the normal atmosphere, and a drop of mercury is injected into the enclosed envelope. Finally, the envelope is sealed.
In operation, the device, now called a "lamp", is connected to an electrical source typically in series with a ballast that provides for 1) ignition of a discharge through the inert-gas-mercury vapor mixture and 2) its subsequent stabilization and sustainment of the electrical behavior of the lamp. Once connected to the applied electric field, free electrons are accelerated through the mercury vapor wherein collisions take place with the mercury atoms. These collisions cause excitation of the electrons in the mercury (Hg) atom and the production of photons at various wavelengths. Certain of these photons travel to the bulb wall and excite the phosphor powder.
6
The phosphor, in turn, emits radiation that is transmitted through the transparent glass envelope. The radiation that is emitted from a standard fluorescent general lighting lamp is primarily in the visible region of the spectrum (380nm-760nm). The radiation that is emitted from an ultraviolet sunlamp is primarily in the UV range of the electromagnetic spectrum (300nm-400nm). Modern day, low pressure ultraviolet sunlamps typically emit most of their energy in the wavelength range that is closest to the visible; that is, in the UVA range (320nm-400nm) range. The emission spectrum of sunlamps usually contains a relatively small proportion of UVB radiation. (260nm-320nm)
Some critical design components and aspects of the sunlamps include:
Glass Bulb (tubular envelope): Must be properly dimensioned and provides for transmission of ultraviolet energy in the range required for tanning.
Phosphor Powder: In addition to proper physical properties such as particle size and aqueous suspension compatibility, the phosphor must emit in the wavelength range required for a particular tanning application. It is the phosphor that primarily determines the spectral irradiance distribution of the radiation from the lamp.
Fill Gas and Pressure: The fill gas (in conjunction with the electrical control gear) determines the electrical characteristics of the lamp and has a large influence on the intensity of the radiation and the temporal depreciation of light output over the usage range.
Coated Electrodes (Cathodes / Coils): Provide a surface area for cathode coating and to a great extent influence starting of the lamp and its physical life.
Mercury: Mercury provides the basis for the operation of the lamp. It is through the excitation of mercury atoms and the subsequent quenching of the excited atoms in the vapor state that "light" is produced. It is the shortwave UV photons that resulting from the excitations that excite phosphor to produce light in a specific spectral range.
Bases: Allow the lamp to be installed in appropriate sockets for electrical connectivity to the electrodes.
7
For illustrative purposes:
Image /page/7/Figure/2 description: This image is a diagram of a typical hot cathode fluorescent lamp. The diagram labels the different parts of the lamp, including the bulb, phosphor, cathode, exhaust tube, base, mercury, gas, stem press, and lead-in wires. The diagram also includes descriptions of each part, such as the bulb being a straight glass tube and the phosphor being a coating inside the bulb that transforms ultraviolet radiation into visible light.
Intended Use/Indications for Use
INTENDED USE: Wolf System sunlamps are intended for use in sunlamp products for tanning of the human skin.
Technological Characteristics
The technological characteristics of the ultraviolet sunlamps which are the subject of this 510(k) are identically the same as the technological characteristics of the predicate devices. The tables and data that are reported in Section 10 and the information summarized in Section 12, "Substantial Equivalence Discussion" of this 510(k), document that there are no significant differences between the subject and predicate devices. In fact, the subject and the predicate devices are "one in the same".
Performance Testing Summary
- . All lamps are 100% tested for functionality at the end of the manufacturing process. Lamps that do not meet critical characteristics for functionality and safety are rejected.
- According to a Quality Sampling Plan, lamps are tested in-process and / ● or post-production for:
-
Electrical Characteristics and Safety
-
Mechanical Safety
-
Dimensional Integrity
-
Physical Design Attributes
-
8
-
UV radiation Characteristics, including:
- UVA Irradiance
- Erythemal Effective Irradiance .
- UVC/UVB ratio per 21 CFR 1040.20 .
As noted, the subject lamps of this 510(k) are identical to the predicate devices. Therefore, the subject lamps and the predicate devices have the same performance requirements.
| Test (Performance Criteria | Lamps meet criteria of predicate
devices (Yes/No) |
|-----------------------------------------|------------------------------------------------------|
| Functionality / Light up | Yes |
| Electrical Characteristics | Yes |
| Burn-in Behavior | Yes |
| Dimensional Characteristics | Yes |
| Mechanical Safety | Yes |
| Electrical Safety | Yes |
| Physical Design (e.g., reflector angle) | Yes |
| UV Performance | Yes |
| UVA Irradiance | Yes |
| Erythemal Effective Irradiance | Yes |
| UVC/UVB Ratio (per 21 CFR1040.20) | Yes |
| | |
Lamps that do not meet Acceptance Criteria are either re-worked, if technically feasible, or scrapped.
9
K151841 Page 7 of 11 5.7
TABLE F-1
WOLFF SYSTEM TECHNOLOGY CORP. ULTRAVIOLET SUNLAMP PRODUCT RANGE
| Wolff System | LAMP DESCRIPTION |
|---|---|
| PART NUMBER | |
| 21015-0 | F71T12 EURO BRONZE MAGNIFIER 7.0 PLUS 100W |
| 21032-0 | F71T12 SOLAR SERIES 1 6.5 PLUS 100W |
| 21126-0 | F71T12 VELOCITY EXTREME 100W |
| 21143-0 | F71T12 DARK TAN 100W |
| 21144-0 | F71T12 DARK TAN Plus 100W |
| 21145-0 | F71T12 DARK TAN II PLUS 100W |
| 21146-0 | F71T12 DARK TAN II 100W |
| 21151-0 | F71T12 ETERNAL SUN SX 100W |
| 21154-0 | F72T12 SOLARIUM VHO RDC |
| 21155-0 | F71T12 ETERNAL SUN HO 100W |
| 21156-0 | F71T12 ETERNAL SUN EX 100W |
| 21158-0 | F71T12 MERIDIAN BRONZER 100W |
| 21160-0 | F71T12 EURO BRONZE PRO MAG 7.0 PLUS 100W |
| 21171-0 | F71T12 VELOCITY PLUS 100W |
| 21174-0 | F71T12 DIAMOND SUN S 100W |
| 21179-0 | F72T12 DIAMOND SUN S 100W |
| 21187-0 | F71T12 VELOCITY 100W |
| 21217-0 | F71T12 SOLAR FLARE MAX 100W |
| 21238-0 | F72T12 HI SUN 9VK VHO |
| 21239-0 | F72T12 EUROBRONZE MAG 7.0 PLUS 160W RDC |
| 21240-0 | F59T12 MERIDIAN BRONZER 100W |
| 21338-0 | F71T12 SUN FUSION BL-FT 100W |
| 21514-0 | F71T12 DARK TAN ELITE 100W |
| 21518-0 | F71T12 XS BRONZING POWER 100W |
| 21629-0 | F71T12 DARQUE TAN 100W |
| 22156-0 | FR24T12 SOLARIUM LR 40W |
| 22224-0 | F73T12 BRONZING SUN PLUS 100W RDC |
| 23001-0 | F71T12 ETS ELITE ULTRA 120W |
| 23002-0 | F71 ETS ELITE WARM TONE100W |
| 23003-0 | F71 ELITE COOL TONE 100W |
| 23004-0 | F71T12 ETS ELITE SELECT 100W |
| 23005-0 | F71T12 ELITE SELECT 120W |
| 23006-0 | F71T12 ELITE PLUS 100W |
| 23007-0 | F71T12 ETS ELITE PLUS 100W |
| 23008-0 | F71T12 X-POWER 100W |
| 23009-0 | F71T12 EURO SUN PLUS S3 100W |
| 23010-0 | FR71T12 ETS ELITE PLUS 100W |
| 23011-0 | FR71T12 ELITE PLUS 120W |
| 23012-0 | F71T12 EVERGLO PLUS 100W |
| Wolff System | LAMP DESCRIPTION |
| PART NUMBER | |
| 23014-0 | F71 X-POWER XP100W |
| 23015-0 | FR59T12 PRO TECH W Intensive R-UVA 80W |
| 23016-0 | FR71T12 PRO TECH W Intensive R-UVA 100W |
| 23017-0 | FR71T12 ORIGINAL SUN FLAGSHIP R PLUS 100W |
| 23018-0 | FR59T12 GOLDENBRONZE 140W |
| 23019-0 | F71T12 GOLDENBRONZE 100-120W |
| 23020-0 | FR71T12 ETS ELITE VZR 160W |
| 23021-0 | FR71T12 ELITE SELECT 160W |
| 23022-0 | FR71T12 ETS ELITE ULTRA 160W |
| 23023-0 | FR71T12 ELITE ULTRA 160W |
| 23024-0 | FR71T12 ETS ELITE JK90 160W |
| 23025-0 | FR71T12 ETS ELITE ULTRA 180-200W |
| 23027-0 | FR71 INFERNO 160X 160W |
| 23028-0 | F71T12 GOLDENBRONZE Maximum 100-120W |
| 23029-0 | F73T12 GOLDENBRONZE Maximum 100-120W RDC |
| 23030-0 | F71T12 GOLDENBRONZE VHO 160W |
| 23031-0 | FR79T12 ETS ELITE ULTRA / 200W |
| 23032-0 | FR79T12 ELITE ULTRA 200W |
| 23033-0 | FR79T12 GOLDENBRONZE 180-200W |
| 23034-0 | FR71T12 GOLDENBRONZE 100-120W |
| 23035-0 | FR73T12 GOLDENBRONZE 100W |
| 23036-0 | FR71T12 GOLDENBRONZE Plus 100-120W |
| 23037-0 | FR71T12 GOLDENBRONZE 160W |
| 23038-0 | FR71T12 GOLDENBRONZE Plus160W |
| 23039-0 | FR71T12 GOLDENBRONZE 200W |
| 23040-0 | F71T12 MASTER BRONZE 100-120W |
| 23041-0 | F73T12 ETS ELITE SELECT 120W |
| 23042-0 | FR75T12 PRO TECH W Intensive R-UVA 110W |
| 23043-0 | F71T12 GOLDENBRONZE Plus 100-120W |
| 23044-0 | F73T12 GOLDENBRONZE 100-120W RDC |
| 23045-0 | F71T12 GOLDENBRONZE II 100-120W |
| 23046-0 | F73T12 GOLDENBRONZE II 100-120W |
| 23047-0 | FR71T12 MASTER BRONZE 100-120W |
| 23048-0 | FR71T12 MASTER BRONZE 160W |
| 23049-0 | FR71T12 MASTER BRONZE 180-200W |
| 23050-0 | FR71T12 MASTER BRONZE Plus 160W |
| 23051-0 | F59T12 ETS ELITE 80W |
| 23052-0 | F59T12 GOLDEN BRONZE 80W |
| 23053-0 | FR59T12 GOLDEN BRONZE 80W |
| 23054-0 | F71T12 SUNFIRE 100W |
| 23055-0 | F71T12 SUNFIRE POWER WINDOW 100W |
| 23056-0 | FR79T12 ZOOM TAN VHO ZT 180W |
| 23057-0 | F71T12 SUNFIRE PLUS 100W |
| 23060-0 | FR75 SUNFIRE Intensive R-UVA 110W |
| 23061-0 | FR71 SUNFIRE Intensive R-UVA 110W |
| Wolff System | |
| PART NUMBER | LAMP DESCRIPTION |
| 23074-0 | F73T12 EVERGLO PLUS 100W RDC |
| 23075-0 | F73T12 EURO SUN PLUS S3 100W |
| 23076-0 | F73T12 DOMINION PLUS 100W RDC |
| 23101-0 | F25T5 D-Light |
| 23102-0 | F25T5 INFERNO |
| 25984-0 | F59T12 EURO BRONZE MAGNIFIER 7.0 PLUS 80W |
| 25993-0 | F59T12 VELOCITY 80W |
| 25996-0 | F71T12 SOLAR Rayz 100W |
| 25999-0 | F73T12 DARQUE TAN 100W |
| 26000-0 | FR71T12 BRONZING SUN PLUS 100W |
| 26007-1 | F71T12 INFERNO BL XP 100W |
| 26015-0 | F71T12 HOLLYWOOD TANS 42 100W |
| 26022-0 | F71T12 BRONZING SUN ULTRA 120W BiPin |
| 26045-0 | F71T12 BELLARIUM S 100W |
| 26048-0 | F73T12 BELLARIUM S 100W |
| 26072-0 | F73T12 VELOCITY 100W RDC |
| 26094-0 | F73T12 DARK TAN II 100W |
| 26104-0 | F73T12 ETERNAL SUN SX 100W |
| 26127-0 | FR71T12 DARKTAN II PLUS 100W |
| 26128-0 | F73T12 SOLARIUM VHO RDC |
| 26129-0 | F71T12 BRONZING SUN PLUS 100W |
| 26133-0 | F73T12 MERIDIAN BRONZER 100W RDC |
| 26136-0 | F73T12 DARQUE TAN PLUS 100W RDC |
| 26138-0 | F71T12 BRONZING SUN HPK90 100W |
| 26140-0 | F71T12 DOMINION PLUS 100W |
| 26146-0 | F73T12 DARK TAN II PLUS 100W |
| 26157-0 | F73T12 ETERNAL SUN EX 100W |
| 26160-0 | F71T12 HI SUN 9VK SOLAR SERIES-1 100W |
| 26164-0 | F73T12 EURO BRONZE PRO MAG 7.0 PLUS 100W |
| 26166-0 | F73T12 VELOCITY HI-WATT 120W |
| 26263-0 | F73T12 DARK TAN ELITE 100W RDC |
| 26266-0 | F73T12 XS BRONZING POWER 100W RDC |
| 26268-0 | F73T12 HI SUN 9VK VHO RDC |
| 26269-0 | F73T12 EUROBRONZE MAG 7.0 PLUS VHO-LT RDC |
| 26271-0 | F73T12 VELOCITY PLUS 100W |
| 26277-0 | FR71T12 ORIGINAL SUN 100W |
| 26279-0 | FR71T12 MERIDIAN BRONZER 100W |
| 26293-0 | F73T12 SOLAR SERIES-1 6.5 PLUS 100W RDC |
| 26294-0 | F73T12 MERIDIAN BRONZER 120W RDC |
| 26606-0 | FR59T12 BRONZING SUN 80W |
| 26670-0 | F71T12 VELOCITY SELECT 100W |
| 26671-0 | F71T12 VELOCITY SELECT PLUS 100W |
| 27049-0 | FR71T12 VELOCITY VS-R 160W |
| 27066-0 | FR79T12 BRONZING SUN GOLD 200W |
| 27070-0 | FR59T12 BRONZING SUN 140W |
| Wolff System | |
| PART NUMBER | LAMP DESCRIPTION |
| 27083-0 | FR79T12 BRONZING SUN 180W |
| 27085-0 | FR71T12 BRONZING SUN GOLD 200W |
| 27086-0 | F71T12 BRONZING SUN VHO |
| 27110-0 | FR73T12 SOLARIUM XLR 160W RDC |
| 27111-0 | FR72T12 SOLARIUM XLR 160W RDC |
| 27112-0 | FR71T12 BELLARIUM SR 160W |
| 27123-0 | FR71T12 BRONZING SUN HPK90 100W |
| 27124-0 | FR71T12 BRONZING SUN HP9K-90 PLUS 160W |
| 27137-0 | F71T12 MERIDIAN 160W |
| 27172-0 | FR71T12 BRONZING SUN HPK90 160W |
| 27173-0 | FR71T12 BRONZING SUN HPK90 200W |
| 27176-0 | FR71T12 BRONZING SUN HP9K90 180W |
| 27177-0 | FR71T12 CELSIUS 160W |
| 27197-0 | FR71T12 HT 60/54 II 160W VHO-LT |
| 27202-0 | FR73T12 BRONZING SUN 160W RDC |
| 27205-0 | FR71T12 ORIGINAL SUN 160W LT |
| 27206-0 | FR71T12 ORIGINAL SUN PLUS 160W LT |
| 27207-0 | FR71T12 ORIGINAL SUN 9VK 160W |
| 27208-0 | F73T12 HI SUN 9VK 100W RDC |
| 27209-0 | FR71T12 MERIDIAN BRONZER 160W LT |
| 27211-0 | FR71T12 DARQUE TAN 160W LT |
| 27215-0 | FR71T12 VELOCITY ULTRA 180W BiPin |
| 27221-0 | FR71T12 BRONZING SUN 160W |
| 27223-0 | FR71T12 BRONZING SUN PLUS 160W |
| 27224-0 | FR73T12 BRONZING SUN PLUS 160W RDC |
| 27226-0 | FR71T12 ETERNAL SUN UXR 160W |
| 27248-0 | FR71T12 BRONZING SUN MAG 100W |
| 27251-0 | FR71T12 BRONZING SUN 100W |
| 27261-0 | FR73T12 BRONZING SUN 100W RDC |
| 27282-0 | FR73T12 ORIGINAL SUN 160W LT |
| 27466-0 | F71 SUN FUSION BL-CC 100W |
| 28006-0 | FR79T12 ORIGINAL SUN VHO |
| 28007-0 | FR59T12 ORIGINAL SUN 140W LT |
| 29434-0 | FR73T12 BRONZING SUN ELITE 160W RDC LT |
| 29881-0 | FR71T12 SOLAR RAYZ 160W LT |
| 29889-0 | FR71T12 BRONZING SUN ELITE 160W LT |
| 901756240 | LET RIO-BRONZE-R 71 |
| Wolff System | |
| PART NUMBER | LAMP DESCRIPTION |
| 961232840 | CLEO Advantage 808 100W-R |
| 961234240 | CLEO Advantage 808 100W |
| 963369927 | CLEO Compact S 25W R |
| 971036940 | CLEO Advantage 100W-R |
| 971646027 | CLEO Compact 15W |
| 986566340 | CLEO Advantage 100W |
| 986568740 | CLEO Advantage 100W F73T12 S |
| 986571740 | CLEO Swift 80W R |
| 996000064 | LET RIO Bronze SHR 160W 71 |
| 996000160 | LET RIO Plus SHR 71 |
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K151841
Page 11 of 11 5.11