(92 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical and electrical characteristics of ultraviolet lamps, with no mention of AI or ML technologies.
No
The device is described as an ultraviolet lamp for tanning human skin, which is not considered a therapeutic use. It is explicitly stated as a Class I, 510(k) exempt, medical device for sunlamp products.
No
The device is an ultraviolet lamp intended for tanning human skin, not for diagnosing any medical condition.
No
The device is a physical ultraviolet lamp, not software. The description details its hardware components and manufacturing process.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "for use in sunlamp products for tanning of the human skin." This is a direct interaction with the human body for a cosmetic/therapeutic purpose (tanning), not for examining specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description details a lamp that emits ultraviolet radiation. This aligns with a device used for direct application to the skin, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for external use on the human body for tanning purposes, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
INTENDED USE: This ultraviolet lamp is 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 35 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 high pressure, mercury-metal halide discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the similar to that of commonly used metal halide lamps used for general lighting purposes. 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 quartz envelope, filled with an inert gas (such as argon) and a mixture of mercury and metal halide salts and sealed at both ends.
In principle the radiation created by the metal halide lamp is generated in the same way as in other discharge lamps. The main difference between these high pressure metal halide lamps and the low pressure discharge lamps also used as sunlamp products is in the main mechanism for production of the UV radiation. A low pressure sunlamp depends upon the conversion of short wavelength radiation inside the lamp envelope to higher wavelength radiation (UVA primarily) by a phosphor coating. The metal halide lamp (MHL) derives its radiation characteristics through the direct excitation of mercury and specific metal vapors that are created in the envelope during lamp run-up and stabilized operation. The selection of the particular metal halides, the fill gas composition, and the fill gas pressure are the main determinants of the UV output of the lamp. The physical construction: overall quartz length, diameter, and electrode spacing are variables that are design choices for the engineer in consideration of the lamp power and application requirements. However, it is the selection of the composition of the metallic salts dosed into the lamp envelope during manufacturing that is chief determinant of the spectral output of the lamp.
As with other components, the development of and final design of the metal halide sunlamp is quite dependent upon the application. Depending upon the UV requirements of the tanning equipment, a number of design components may be varied. One of the more critical application related determinants is the fixture design. Among the most critical aspects of the fixture are housing size, reflector type and shape and the cooling arrangement and capabilities. The existence of a myriad of MHL fixtures in the market has led to a wide variety of lamps with different power levels and basing options. MH lamps typically range in power ratings from about 250 W up to 1500 W. Additionally, the lamps come fitted with bases of three main types: Double Ended (clip-in or snap-in) technically named R7s, Single Ended (plug-in) with bases designated as GY9.5, and lamps with Wire Leads (also called cable terminations).
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
Key results indicate that the lamps meet the criteria of predicate devices for:
Functionality / Light up: Yes
Electrical Characteristics: Yes
Burn-in Behavior: Yes
Dimensional Characteristics: Yes
Mechanical Safety: Yes
Electrical Safety: Yes
UVA Irradiance: Yes
Erythemal Effective Irradiance: Yes
UVC/UVB Ratio (per 21 CFR1040.20): Yes
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 shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cosmedico Light, Inc. Steven Schlitt Director Of Engineering And Quality Assurance 233 Libbey Industrial Parkway Weymouth, Massachusetts 02189
October 28, 2015
Re: K152095
Trade/Device Name: Ultraviolet Lamps Intended For Use In Sunlamp Products (commonly Known As "metal Halide Sunlamps") Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet Lamp For Tanning Regulatory Class: Class II Product Code: LEJ Dated: July 24, 2015 Received: July 28, 2015
Dear Steven 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
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 C. Nipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152095
Device Name
Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as "metal halide sunlamps")
Indications for Use (Describe)
INTENDED USE: This ultraviolet lamp is 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Per Sec. 807.92(c)
807.92(a)(1)
| Date Prepared: | July 24, 2015 |
|---|---|
| 510(k) Company / Holder Name: | Cosmedico Light, Inc. |
| Contact Name: | Steven C. Schlitt |
| Title: | Director Engineering & Quality |
| Address: | 233 Libbey Industrial Parkway |
| Weymouth, MA 02189 | |
| Phone Number: | 781-331-0949 (Ext. 107) |
| Fax Number: | 781-331-4766 |
807.92(a)(2)
| Device Proprietary Name: | Various Brands of Ultraviolet Lamps
See attachment F-1 for list of models
and part numbers. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Device Common or Usual Name: | Ultraviolet Sunlamps (Metal Halide Sunlamps) |
| Indication for Use / Intended Use | INTENDED USE: This ultraviolet lamp is
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 |
| Classification Code: | LEJ |
| Regulation Number: | 21 CFR Part 878.4635 |
| Device Classification | II |
4
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), Cosmedico Light 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. 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 35 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 high pressure, mercury-metal halide discharge devices. The general lamp construction and technological principle of operation of all of the devices of this 510(k) is the similar to that of commonly used metal halide lamps used for
5
general lighting purposes. 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 quartz envelope, filled with an inert gas (such as argon) and a mixture of mercury and metal halide salts and sealed at both ends.
In principle the radiation created by the metal halide lamp is generated in the same way as in other discharge lamps. The main difference between these high pressure metal halide lamps and the low pressure discharge lamps also used as sunlamp products is in the main mechanism for production of the UV radiation. A low pressure sunlamp depends upon the conversion of short wavelength radiation inside the lamp envelope to higher wavelength radiation (UVA primarily) by a phosphor coating. The metal halide lamp (MHL) derives its radiation characteristics through the direct excitation of mercury and specific metal vapors that are created in the envelope during lamp run-up and stabilized operation. The selection of the particular metal halides, the fill gas composition, and the fill gas pressure are the main determinants of the UV output of the lamp. The physical construction: overall quartz length, diameter, and electrode spacing are variables that are design choices for the engineer in consideration of the lamp power and application requirements. However, it is the selection of the composition of the metallic salts dosed into the lamp envelope during manufacturing that is chief determinant of the spectral output of the lamp.
As with other components, the development of and final design of the metal halide sunlamp is quite dependent upon the application. Depending upon the UV requirements of the tanning equipment, a number of design components may be varied. One of the more critical application related determinants is the fixture design. Among the most critical aspects of the fixture are housing size, reflector type and shape and the cooling arrangement and capabilities. The existence of a myriad of MHL fixtures in the market has led to a wide variety of lamps with different power levels and basing options. MH lamps typically range in power ratings from about 250 W up to 1500 W. Additionally, the lamps come fitted with bases of three main types: Double Ended (clip-in or snap-in) technically named R7s, Single Ended (plug-in) with bases designated as GY9.5, and lamps with Wire Leads (also called cable terminations).
6
For illustrative purposes, the schematic below points out the main parts of a typical metal halide sunlamp:
Image /page/6/Figure/2 description: This image shows a metal halide lamp with labels pointing to its different parts. The lamp has a quartz tube filled with argon, mercury, and metal halide salts. The lamp also has a ceramic base, molybdenum foil, a tipping nub for exhaust and filling, and a tungsten electrode.
Intended Use/Indications for Use
INTENDED USE: This ultraviolet lamp is 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 contemporary and predicate devices. In fact, the subject/contemporary and the predicate devices are "one in the same".
7
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
-
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 |
| UVA Irradiance | Yes |
| Erythemal Effective Irradiance | Yes |
| UVC/UVB Ratio (per 21 CFR1040.20) | Yes |
8
TABLE F-1
| Item Part Number | Description / Brand |
|---|---|
| 900612555 | ERGOLINE ULTRA 520W |
| 913103645 | CLEO HPA 1200 FX |
| 913132641 | CLEO HPA 250-500 / 30 SD L |
| 913134045 | CLEO HPA 250-500 SE FX |
| 913137141 | CLEO HPA 400 / 30 SD L |
| 913138841 | CLEO HPA 400 / 30 S L |
| 919220245 | CLEO HPA 400 S |
| 919300145 | CLEO HPA 400 / 30 SDC |
| 920669541 | CLEO HPA 700 S FX |
| 920677041 | CLEO HPA 250-500 / 30 SDC |
| 938670245 | CLEO HPA 1010 SE FX |
| 996000101 | ERGOLINE JK 60/80 EF |
| 21104-1 | JK-RUSA 400W R7s |
| 21112-1 | Cosmedico M 650W SE GY9.5 |
| 24003-1 | Cosmedico M 400W R7s |
| 24004-1 | Cosmedico M 400W L |
| 24006-1 | Cosmedico M 500W SE |
| 24008-1 | Cosmedico M 500W L |
| 24022-1 | Cosmedico M 1000W SBSN GY 9.5 |
| 24103-1 | Cosmedico M 1000W L |
| 24171-1 | Cosmedico M 1000W SE GY9.5 |
| 24178-1 | Cosmedico M 800W R7s |
| R02362 | Radiance HP 600-800W GY9.5 |
| R02600 | Radiance HP 1000-1400W L |
| R02606 | Radiance HP 630W P |
| R02609 | Radiance HP 300-520W GY9.5 |
| R02610 | Radiance HP 800-1000W GY9.5 |
| R02611 | Radiance HP 620W L |
| R02614 | Radiance HP 600-650W GY9.5 |
| R02615 | Radiance HP 800-1000W GY9.5c |
| R03060 | Radiance HP 400-500W R7s |
| SQ01400LWL | SUPRA Q-01400LWL |
| SQ01400WL | SUPRA Q-01400WL |
| SQ01400WL4 | SUPRA Q-01400WL4 |
| SQ03520PIJK | SUPRA Q-03520PIJK |
| SQ04500SI | SUPRA Q-04500SI |
| SQ0600PIGYL | SUPRA Q-0600PIGY-L |
| SQ06630R | SUPRA Q-06630R |
| SQ08100PIGYL | SUPRA Q-08100PIGY-L |