(90 days)
The Grivamax Family of Lasers , Models 272 and 148 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II, males who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
The Grivamax Family of Lasers, Models 272 and 148 consist of 272 diode lasers or 148 diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The Grivamax Family of Lasers, Models 272 and 148 are powered by a lithium-ion battery pack that contains an embedded controller chip.
This document is a 510(k) Summary for the Grivamax Family of Lasers, Models 272 and 148. The submission argues for substantial equivalence to previously cleared predicate devices, the Diode Laser Cap (K173678) and the Grivamax Hair Growth System (K171895).
Summary of Acceptance Criteria and Device Performance:
The primary basis for acceptance of the Grivamax Family of Lasers (Models 272 and 148) is its substantial equivalence to the predicate devices. The sponsor argues that the proposed devices are identical to the predicate devices in all relevant aspects. Therefore, the "reported device performance" for the proposed devices is effectively the performance demonstrated by the predicate devices.
Here's a table summarizing the shared characteristics and performance attributes that form the basis for substantial equivalence:
| Specification Category | Acceptance Criteria (Based on Predicate Performance) | Reported Device Performance (Proposed Devices) | Outcome |
|---|---|---|---|
| LLLT Device Type | Laser Diode | Laser Diode | Met |
| Use Application | OTC | OTC | Met |
| Intended Use (Androgenetic Alopecia) | Androgenetic Alopecia | Androgenetic Alopecia | Met |
| Contain Laser Diodes | 272 or 148, 5 milliwatts each, Class 3R | 272 or 148, 5 milliwatts each, Class 3R | Met |
| Physical Design of Device | Helmet | Helmet | Met |
| Wavelength | 650+/-5 NMS | 650+/-5 NMS | Met |
| Marketing Clearance | For females and males, OTC | For females and males, OTC | Met |
| Use Type | Passive Use-Hands Free | Passive Use-Hands Free | Met |
| Classification Code | OAP | OAP | Met |
| Classification Name | Infrared Lamp | Infrared Lamp | Met |
| Common Usage Name | Lamp, Non-Heating | Lamp, Non-Heating | Met |
| Classification Panel | General & Plastic Surgery | General & Plastic Surgery | Met |
| Skin Phototypes | I-IV | I-IV | Met |
| Hair Loss Classification | Hamilton-Norwood IIa-V for males; Ludwig-Savin I-II for females | Hamilton-Norwood IIa-V for males; Ludwig-Savin I-II for females | Met |
| Treatment Regime | 16 weeks, 30-minute treatment times, three times a week, on alternate days. | 16 weeks, 30-minute treatment times, three times a week, on alternate days. | Met |
| Device Class | II | II | Met |
| Optical Function | Identical to predicate | Identical to predicate | Met |
| Electronic Function | Identical to predicate | Identical to predicate | Met |
| Mechanical Function | Identical to predicate | Identical to predicate | Met |
| Aesthetic Appearance | Identical to predicate | Identical to predicate (same exterior black shell and interior clear shells; dimensions are equivalent) | Met |
| Adverse Event Profile | Same as predicate | Same as predicate (no difference in physical appearance or method of delivering radiant energy implies no variation in therapeutic value or safety profile) | Met |
| Electrical Safety & EMC | Conformance to IEC 60825-1 Ed 3.0 2014 and IEC 60601-1-2-22 Ed 3.1 2012-10 (for predicates) | Not evaluated for conformance; stated as identical to predicates and thus implicitly compliant | N/A (Relied on predicate data) |
Study Information (or lack thereof, as per the submission):
-
Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable. No new clinical performance data was generated for this submission. The submission relies entirely on the demonstration of substantial equivalence to previously cleared predicate devices.
- Data provenance: Not applicable for this submission. The predicates (Diode Laser Cap K173678 and Grivamax Hair Growth System K171895) would have had their own clinical data, but this information is not provided in this document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new clinical performance data or test set requiring expert ground truth establishment was conducted for this submission.
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Adjudication method for the test set:
- Not applicable. No new clinical performance data or test set requiring adjudication was conducted for this submission.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a laser therapy product for hair growth, not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device for therapy, not a standalone algorithm.
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The type of ground truth used:
- Not applicable for this submission. The "ground truth" for the safety and efficacy of the device is implicitly taken from the prior clearance of the predicate devices based on their historical clinical studies (which are not detailed here).
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The sample size for the training set:
- Not applicable. No new training data or training set was used for this 510(k) submission.
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How the ground truth for the training set was established:
- Not applicable. No new training data or training set was used for this 510(k) submission.
Key Point:
The entire argument for the Grivamax Family of Lasers (K211192) meeting acceptance criteria rests on the assertion that it is "identical" to two previously cleared predicate devices (Diode Laser Cap K173678 and Grivamax Hair Growth System K171895) which are manufactured by the same company (Cosmo Far East Technology Limited) for private labeling. The submission explicitly states: "No clinical performance data was produced for this submission because the Grivamax Family of Lasers, Models 272 and 148 are the same device as the Cleared predicates... They are the same device in optical, electronic, mechanical function and aesthetic appearance, as well as the same recommended clinical treatment regime."
Therefore, the "study that proves the device meets the acceptance criteria" in this case is a comparison of technical specifications and intended use demonstrating no differences from the predicate devices that would raise new questions of safety or effectiveness. The previous clearances of the predicate devices implicitly contain the studies and acceptance criteria that established their safety and efficacy.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.