(215 days)
Not Found
No
The summary describes a diode laser device for hair reduction and wrinkle treatment. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in the device description, intended use, or performance studies.
Yes
The device is intended for hair reduction (long-term, stable reduction in hair regrowth) and treatment of wrinkles, which are conditions that impact the structure or function of the body, classifying it as a therapeutic device.
No
The "Intended Use / Indications for Use" section states that the device is intended for "hair reduction" and "treatment of wrinkles," both of which are therapeutic cosmetic procedures, not diagnostic ones. The "Device Description" also explains how it acts on tissues to remove hair and treat wrinkles, further confirming its therapeutic nature.
No
The device description explicitly states that the device consists of a power adapter, a power cord, and a main unit, indicating it includes hardware components.
Based on the provided information, the DermRays Revive device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are "hair reduction" and "treatment of wrinkles." These are therapeutic and cosmetic procedures performed directly on the patient's body.
- Device Description: The device uses a laser to act on tissues within the body (dermis, hair follicles).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The DermRays Revive is a medical device that interacts directly with the patient's body for treatment purposes, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
DermRays Revive is intended for hair reduction. Permanent hair reduction is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
DermRays Revive is also intended for treatment of wrinkles.
DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
DermRays Revive uses a diode laser with an output wavelength of 1064nm, to act on the dermis through the epidermis, and the laser energy is absorbed by the target tissues (melanin, hemoglobin, and water).
Due to the selective photothermal effect of the laser, it can treat wrinkles, without damaging the skin. Simutaneously, the laser can act on the melanin in the hair follicles, destroy hair follicles in the growth around the hair follicles, so as to remove hairs.
The device consists of a power adapter, a power cord and a main unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-Clinical Tests Submitted:
Biocompatibility Testing:
According to ISO 10993-1:2018, we performed biocompatibility test for the parts that may directly contact the intact skin of the patient or operator, including in vitro cytotoxicity test per ISO 10993-5:2009, skin sensitization test per ISO 10993-10:2021, irritation test per ISO 10993-23:2021.
Electrical Safety and Electromagnetic Compatibility Testing:
The propoesd device was tested and complicable requirements of the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-22 and IEC 60825-1, demonstrated that the basic safety and performance of the device met the requirements.
Software Verification and Validation:
Software verification and validation was performed, and it was demonstrated that the software performs as intended according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Concise summary for performance testing:
From the performance testing - bench, we have a brief summary as follow:
- Performance Test: Appearance, Function, Safety, Label.
- Shelf Life Test: Accelerated aging test, and performance test after accelerated aging test).
- Cleaning and Disinfection Verification: Simulated cleaning and disinfection test, and performance test after simulated cleaning and disinfection test.
All the bench test results are provided in Performance Test Report.
No clinical testing has been performed.
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.
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
§ 878.4810 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 30, 2024
Wuhan Lotuxs Technology Co., Ltd. Na Wu, Quality Manager 501/E2, No.999 High-tech Avenue Wuhan, Hubei 430206 China
Re: K231910
Trade/Device Name: DermRays Revive Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: December 13, 2023 Received: December 13, 2023
Dear Na Wu:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tanisha L. Hithe Tanisha L. s 2024.01.30 Hithe -S 14:57:30 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231910
Device Name DermRays Revive (LHR-S5-1064)
Indications for Use (Describe)
DermRays Revive is intended for hair reduction. Permanent hair reduction is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
DermRays Revive is also intended for treatment of wrinkles.
DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned 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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4
Section 5 - 510(k) Summary K231910
Date of Summary Preparation: June 25, 2023 Date of Summary Modification: January 09, 2024
1. Submitter's Identifications
Submitter's Name: Wuhan Lotuxs Technology Co., Ltd. Address: 501/E2, No.999 High-tech Avenue, Wuhan 430206, China Contact Person: Na Wu Contact Title: Quality Manager Contact Email Address: na.wu@lotuxs.com Telephone: +86-27-87619668
2. Correspondent's Identifications
Correspondent's Name: Wuhan Lotuxs Technology Co., Ltd. Address: 501/E2, No.999 High-tech Avenue, Wuhan 430206, China ZIP Code: 430206 Contact Person: Na Wu Contact Title: Quality Manager Contact E-mail Address: na.wu(@)lotuxs.com Telephone: +86-27-87619668
3. Name of the Device
Device Classification Name: Powered laser surgical instrument Product Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Trade Name: DermRays Revive Model: LHR-S5-1064 Classification Panel: General & Plastic Surgery Product Code: GEX Regulation Number: 21 CFR 878.4810 Device Classification: Class II
4. The Predicate Devices
Primary predicate device: K141425 Cynosure Elite+ Laser Secondary predicate device: K232117 Diode Laser Hair Removal
5. Device Description
DermRays Revive uses a diode laser with an output wavelength of 1064nm, to act on the dermis through the epidermis, and the laser energy is absorbed by the target tissues (melanin, hemoglobin, and water).
Due to the selective photothermal effect of the laser, it can treat wrinkles, without damaging the skin. Simutaneously, the laser can act on the melanin in the hair follicles, destroy hair follicles in the growth around the hair follicles, so as to remove hairs.
The device consists of a power adapter, a power cord and a main unit.
5
6. Intended Use of Device
DermRays Revive is intended for hair removal, permanent hair reduction. 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 regime. DermRays Revive is also intended for treatment of wrinkles.
DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
7. Summary of Substantial Equivalence
| | Proposed device | Primary predicate
device | Secondary predicate
device | Comparison |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510k
Number | K231910 | K141425 | K232117 | — |
| Product
Code | GEX | GEX | GEX | — |
| Proprietary
Name | DermRays Revive | Cynosure Elite+ Laser | Diode Laser Hair
Removal | — |
| Model | LHR-S5-1064 | / | LHR-V6S-1064,
LHR-V6S/B-1064 | — |
| Manufacture | Wuhan Lotuxs
Technology Co., Ltd. | Cynosure LLC | Wuhan Lotuxs
Technology Co., Ltd. | — |
| Indications
for use | DermRays Revive is
intended for hair
removal, permanent
hair reduction.
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 regime.
DermRays Revive is
also intended for
treatment of wrinkles.
DermRays Revive is
intended for use on all
skin types (Fitzpatrick
skin types I - VI),
including tanned skin. | 1064 nm:
The Cynosure Elite+
Laser is intended for
the coagulation and
hemostasis of benign
vascular lesions such
as, but not limited to,
port wine stains,
hemangiomas, warts,
telangectasia, rosacea,
venus lake, leg veins,
spider veins and
poikiloderma of civatte;
and treatment of benign
cutaneous lesions such
as warts, scars, striae
and psoriasis. The laser
is also intended for the
treatment of benign
pigmented lesions such
as, but not limited to,
lentigos (age spots),
solar lentigos (sun | Diode Laser Hair
Removal
(LHR-V6S-1064,
LHR-V6S/B-1064) is
intended for hair
removal, permanent
hair reduction.
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 regime.
Diode Laser Hair
Removal
(LHR-V6S-1064,
LHR-V6S/B-1064) is
intended for use on all
skin types (Fitzpatrick
skin types I - VI), | Same |
| | | | | |
| | | spots), cafe au lait
macules, seborrheic
keratoses, nevi,
chloasma, verrucae,
skin tags, keratosis and
plaques.
The laser is also
indicated for the
treatment of wrinkles
such as, but not limited
to, periocular and
perioral wrinkles.
Additionally, the laser
is indicated for the | | |
| | | treatment of
pseudofolliculitis
barbae (PFB) and for
stable long-term, or
permanent hair
reduction. Permanent
hair reduction is
defined as long-term
stable reduction in the
number of hairs
regrowing when
measured at 6, 9 and 12
months after the
completion of a
treatment regime. | including tanned skin. | |
| Laser Type | Solid state | Solid state | Solid state | Same |
| Wavelength | 1064nm±10nm | 1064nm±10nm | 1064nm±10nm | Same |
| Treatment
Activation | Fingerswitch | Fingerswitch | Fingerswitch | Same |
| Rx/OTC | Prescription | Prescription | Prescription | Same |
| Pulse Width | 400ms | 0.1ms-300ms | LHR-V6S-1064:
350ms-450ms
LHR-V6S/B-1064:
280ms-400ms | Same1 |
| Single Pulse
Max. Energy
Density | $5.0J/cm^2$ - $10.0J/cm^2$ | $4.7J/ cm^2$ (under 24mm
handpiece spot size)
$12.0J/cm^2$ (under 15mm
handpiece spot size) | LHR-V6S-1064:
$5J/cm^2$ , $6 J /cm^2$ , $7J/cm^2$
LHR-V6S/B-1064:
$4J/cm^2$ , $5J/cm^2$ , $6J/cm^2$ | Similar2 |
| | | | | |
| Handpiece
Spot Size | 15mm | 3mm, 5mm, 7mm,
10mm, 12mm, 15mm,
18mm, 20mm, 22mm
& 24mm | 30mm×10mm | Same3 |
| Working
Area | 1.766cm2 | 4.522cm2 (under 24mm
handpiece spot size)
1.766cm2 (under 15mm
handpiece spot size) | 3cm2 | Same3 |
| Input
Voltage | AC100-240V,
50/60Hz, 1.6A Max. | 208/240VAC, 30A,
50/60Hz, Single Phase | AC100-240V,
50/60Hz, 1.6A Max. | Same4 |
Table 1
6
7
Note 1: Pulse Width of the proposed device is same as the secondary predicate device LHR-V6S/B-1064 of K232117.
Note 2: Maximum energy density of a single pulse of the proposed device is similar to those of the primary predicate device K141425 (1064nm) and secondary predicate device K232117. These slight differences do not affect to safety and effectiveness of the proposed device.
Note 3: Handpiece Spot Size and Working Area of the proposed device are same to those of the secondary predicate device K141425 (15mm, 1.766 cm-).
Note 4: Input Voltage of the proposed device is same as the secondary predicate device K232117.
Discussion for Substantially Equivalent (SE):
The proposed device DermRays Revive LHR-S5-1064 has the same indications for use, laser type, wavelength, treatment activation, prescription, pulse width, handpiece spot size and working area, input voltage; has similar single pulse max. energy density. These different items can be controlled within the scope of application. These slight differences between the proposed devices and predicate devices do not cause new safety and effectiveness problems. According to the non clinical test results and use evaluation report, the proposed device is as safe, effective and has good performance as the predicate device.
So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.
8. Non-Clinical Tests Submitted
The following non-clinical testing was provided in this 510(k) submission:
Biocompatibility Testing
8
According to ISO 10993-1:2018, we performed biocompatibility test for the parts that may directly contact the intact skin of the patient or operator, including in vitro cytotoxicity test per ISO 10993-5:2009, skin sensitization test per ISO 10993-10:2021, irritation test per ISO 10993-23:2021.
Electrical Safety and Electromagnetic Compatibility Testing
The propoesd device was tested and complicable requirements of the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-22 and IEC 60825-1, demonstrated that the basic safety and performance of the device met the requirements.
Software Verification and Validation
Software verification and validation was performed, and it was demonstrated that the software performs as intended according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
9. Concise summary for performance testing
From the performance testing - bench, we have a brief summary as follow:
-
Performance Test: Appearance, Function, Safety, Label.
-
Shelf Life Test: Accelerated aging test, and performance test after accelerated aging test).
-
Cleaning and Disinfection Verification: Simulated cleaning and disinfection test, and performance test after simulated cleaning and disinfection test.
All the bench test results are provided in Performance Test Report.
10. Clinical Study
No clinical testing has been performed.
11. Conclusions
After analyzing both bench and external laboratory testing data, the intended use and supporting data can conclude that the device in the submission is substantially equivalent to the predicate device.