(286 days)
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No
The summary describes a laser device for hair removal and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is described as a laser instrument for the removal of unwanted body and facial hair, which is a therapeutic purpose. The summary of performance studies also discusses hair density reduction as a treatment outcome.
No
Explanation: The device is indicated for the removal of unwanted body and facial hair, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it is a "laser instrument," which is a hardware device.
Based on the provided information, the Mehl QD Ruby Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "removal of unwanted body and facial hair." This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. The Mehl QD Ruby Laser does not interact with such specimens.
- Device Description: The description reinforces its use as a laser instrument for hair removal, not for analyzing biological samples.
Therefore, the Mehl QD Ruby Laser falls under the category of a therapeutic or cosmetic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Mehl QD Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial hair.
Product codes (comma separated list FDA assigned to the subject device)
79GEX
Device Description
The Mehl QD Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial hair.
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 facial hair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practice
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)
The ability of the ruby laser to remove hair was measured in three clinical studies. In one of these studies, 38.4% of the sites receiving only one treatment showed a 100% reduction in hair density after an average of 72 days. In all three studies, no safety issues were identified. No scarring or purpuric reactions were observed, though skin discoloration (hyper- and hypopigmentation) was noted, but was seen to resolve within a few months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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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
KG 2109
MAR 1 3 1997
ਾਰਜ
ਹੈ ਜਾਂਦੀ
ਹੈ ਜਾਂ
4020 Newberry Road Suite 400 Gainesville, Florida 32607 Phone (352) 373-2565 FAX (352) 373-2481
510(k) SUMMARY
MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL
The Mehl QD Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial hair. Reviewed by the General and Plastic Surgery Device Classification Panel, medical lasers are assigned the Product Code 79GEX and are regulated under 21 CFR 878.4810 as Class II (Performance Standards) devices.
From an operational standpoint the Mehl OD Ruby Laser is substantially equivalent to any number of laser devices, including the Spectrum Model RD-1200 (K910422), used in Dermatology practice. They produce the same wavelength, deliver the same energies to the skin, and are constructed of similar components.
With respect to its patented procedure for removing hair, the Mehl QD Ruby Laser is substantially equivalent to the ThermoLase LT-100 Q-Switched Nd: YAG laser (K950019) in that,
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- Both types of lasers are widely used for dermatological applications;
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- Each is based upon the same technological characteristics;
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- Both employ the same principle of selective photothermolysis for depilitation, although the Mehl laser achieves the same or better effect without the use of the carbon-based lotion and pretreatment waxing required by the ThermoLase system;
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- The ability of the ruby laser to remove hair was measured in three clinical studies. In one of these studies, 38.4% of the sites receiving only one treatment showed a 100% reduction in hair density after an average of 72 days.
In all three studies, no safety issues were identified. No scarring or purpuric reactions were observed, though skin discoloration (hyper- and hypopigmentation) was noted, but was seen to resolve within a few months.
Roma Blake 5/29/96
Date
Thomas Blake, R.Ph. REGULATORY STRATEGIST
172