(65 days)
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No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The description focuses on the physical characteristics, principle of operation, and standard performance testing for a light-based hair removal device.
Yes
The device is described as "intended to provide phototherapeutic light to the body", which indicates a therapeutic purpose. Additionally, its primary intended use is "removal of unwanted hair" through "selective photothermal treatment" and "permanent reduction in unwanted hair", all of which are therapeutic interventions.
No
The device is described as providing phototherapeutic light and for hair removal, which are therapeutic and cosmetic purposes, not diagnostic. A diagnostic device would be used to identify or analyze a disease or condition.
No
The device description explicitly states it is an "AC Powered, Personal Light-Based Hair Removal System" with a physical weight and dimensions, and includes a "limited life lamp cartridge," indicating it is a hardware device that uses light for treatment.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device, the Lumena FH, is applied directly to the body (skin) for hair removal.
- The intended use and device description clearly state its purpose is phototherapeutic light application and hair removal. This involves interacting with the body's surface, not analyzing biological samples.
- There is no mention of analyzing blood, urine, tissue, or any other biological specimen.
The Lumena FH is a light-based device for cosmetic/therapeutic purposes applied externally to the body.
N/A
Intended Use / Indications for Use
Lumena FH is an over the counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Lumena FH is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Product codes
ONF
Device Description
Over-The-Counter, AC Powered, Personal Light-Based Hair Removal System. Emission activation is by fingerswitch. Device includes a limited life lamp cartridge. Overall weight of the device is 1.0 Kg, and the size is 22 x 16 x 78 cm (HxWxD). The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Electrical Requirement is 115-230 VAC, 50-60 Hz, 1.3A single phase.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Body and/or Facial hair
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home-use environment (OTC)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Label comprehension and usability test of consumers' ability to understand the instructions for use and to evaluate their ability to use the device safely in a simulated OTC home-use environment.
- 150 study subjects were tested for label comprehension and 123 study subjects tested for usability. Both test populations included low literacy subjects.
The results of the two tests confirm sufficient label comprehension and safe and appropriate use of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Shaser V-MINI 2 Hair Removal System K133201
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
K140631 MAY 1 6 7014
510(K) Summary
| Submitter: | Shaser, Inc.
10 Maguire Road
Building 1
Lexington, MA 02421 | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Anthony Burns
Senior Director of Regulatory Affairs | |
| Date Summary Prepared: | May 13, 2014 | |
| Device Trade Name: | Lumena FH Hair Removal System | |
| Common Name: | Light based hair removal device | |
| Classification Name: | Powered Light Based Non-Laser Surgical Instrument with Thermal
Effect. Product Code ONF | |
| Equivalent Device: | Shaser V-MINI 2 Hair Removal System | |
| Device Descripton: | Over-The-Counter, AC Powered, Personal Light-Based Hair Removal
System. Emission activation is by fingerswitch. Device includes a
limited life lamp cartridge. Overall weight of the device is 1.0 Kg, and
the size is 22 x 16 x 78 cm (HxWxD).
The Principle of Operation is selective photothermolysis and the
Mechanism of Operation is to disable hair growth using light to | |
| | preferentially heat the hair bulb.
Electrical Requirement is 115-230 VAC, 50-60 Hz, 1.3A single
phase. | |
| Intended Use: | Removal of unwanted hair. | |
| Indication for Use: | Lumena FH is an over the counter device intended to provide
phototherapeutic light to the body. It is also intended for removal of
unwanted hair by using a selective photothermal treatment. It is also
indicated for the removal of unwanted body and/or facial hair in adults
with Fitzpatrick skin types I - IV. The Lumena FH is also intended
for permanent reduction in unwanted hair. Permanent hair reduction is
defined as the long-term stable reduction in the number of hairs
regrowing when measured at 6, 9, and 12 months after the completion
of a treatment regimen. | |
| Comparison: | The Lumena FH Hair Removal System has the same indication for
uses, the same principle of operation, the same pulse energy range and
wavelength range as the Shaser V-MINI 2 Hair Removal System. | |
| Exhibit E - (1 of 3) | | |
1
| Proposed Modified Device | Predicate Device 510(k) K133201 | |
|---|---|---|
| Manufacturer | Shaser, Inc. | Shaser, Inc. |
| Trade Name | Lumena FH Hair Removal System | Shaser V-MINI 2 Hair Removal System |
| Indications | Lumena FH is an over the counter device | |
| intended to provide phototherapeutic light to | ||
| the body. It is also intended for removal of | ||
| unwanted hair by using a selective | ||
| photothermal treatment. It is also indicated | ||
| for the removal of unwanted body and/or | ||
| facial hair in adults with Fitzpatrick skin | ||
| types I – IV. The Lumena FH is also | ||
| intended for permanent reduction in | ||
| unwanted hair. Permanent hair reduction is | ||
| defined as the long-term stable reduction in | ||
| the number of hairs regrowing when | ||
| measured at 6, 9, and 12 months after the | ||
| completion of a treatment regimen. | Shaser V-MINI 2 is an over the counter | |
| device intended to provide phototherapeutic | ||
| light to the body. It is also intended for | ||
| removal of unwanted hair by using a | ||
| selective photothermal treatment. It is also | ||
| indicated for the removal of unwanted body | ||
| and/or facial hair in adults with Fitzpatrick | ||
| skin types I – IV. The Shaser V-MINI 2 is | ||
| also intended for permanent reduction in | ||
| unwanted hair. Permanent hair reduction is | ||
| defined as the long-term stable reduction in | ||
| the number of hairs regrowing when | ||
| measured at 6, 9, and 12 months after the | ||
| completion of a treatment regimen. | ||
| 'Use | ||
| Classification' | OTC | OTC |
| Device Type | Intense Pulsed Light | Intense Pulsed Light |
| Wavelength | ||
| range (nm) | 400nm – 1200nm | 400nm – 1200nm |
| Fluence Settings | 1 = 6 (J/cm²) | |
| 2 = 7 (J/cm²) | ||
| 3 = 8 (J/cm²) | ||
| 4 = 9 (J/cm²) | ||
| 5 = 10 (J/cm²) | 1 = 6 (J/cm²) | |
| 2 = 8 (J/cm²) | ||
| 3 = 10 (J/cm²) | ||
| Spot Size (mm) | 2cm² | 2cm² |
| Pulse Width (ms) | Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov |
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