WARNING LETTER
Ostar Beauty Sci-Tech Co Ltd.
MARCS-CMS 667871 —
December 04, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Carey Har
Recipient Title
CEO
Ostar Beauty Sci-Tech Co Ltd.
3-2-602, Star Park II
Daxing Qu
Beijing Shi
,
100162
China
Issuing Office:
OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality
United States
WARNING LETTER
CMS: #667871
December 04, 2023
Dear Mr. Carey Har:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the following products in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act):
3 Levels Injection Insulin Gun Hyaluronic Acid Skin Injection Needle Free Pen
Derma Pens:
o  Powered LED Microneedling Device Rechargeable Dermapen for Acne and Stretchmarks Removal
o  Power Microneedling device Anti Backflow LCD Dermapen LED Therapy
o  Red LED Vibrating Photon 540 600 Needles Microneedling Derma Roller
LED Masks:
o  Rechargeable Silicone Bendable Gene Biology LED Facial Light Therapy Mask
o  OstarBeauty Wireless 7 Color LED Light Therapy Facial Mask with Neck
o  LED PDT Phototherapy LED Light Beauty Machine for Face and Body Treatment
Personal Care Devices:
o  Supper Effective 650nm Laser Hair Growth Helmet Cap
o  Home Cryolipolysis Fat Freezer Weight Loss Body Shape CryoPad
o  Electroporation Mesotherapy Needle-Free Injection Beauty Machine
Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.
The FDA has reviewed your firm's website and determined that the devices listed above are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because for each of the above listed devices your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because for each of the above listed devices your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency (21 CFR 807.81(b)). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://wvvw.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HovvtoMarketYourDevice/d efault.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our review of your firm's website (https://wvvvv.ostarbeauty.com/, last accessed on 11/29/2023), revealed claims such as the following:
3 Levels Injection Insulin Gun Hyaluronic Acid Skin Injection Needle Free Pen (Model Number: OB-N 04)
1
"The hyaluron pen is a device that provides a quick administration of hyaluronic acid into your skin. Plump your lips, fill in fine lines and wrinkles, make your skin brightly and smoothing."
"Depth of skin" — "6-8nun(mesoderm of skin)"
"Through the pressure technology the pen uses pressure which causes the Hyaluronic Acid to turn into Nano Scale molecules and inserts the Hyaluronic acid Filler through the skin. The Diameter of this flow is 0.17 mm, twice as small as the smallest insulin needle."
"Wrinkle removal."
Claims or statements of penetration or some effect beyond the stratum corneum into living layers of skin by such products show an intent to cure, mitigate, treat or prevent disease or affect the structure or any function of the body. See FD&C Act § 201(h). Based on the claims and statements on your firm's website, 3 Levels Injection Insulin Gun Hyaluronic Acid Skin Injection Needle Free Pen, is a device because it is intended for use in the "cure, mitigation, treatment, or prevention of disease" or "intended to affect the structure or any function of the body" (e.g., "provides a quick administration of hyaluronic acid into your skin," "inserts the Hyaluronic acid Filler through the skin" to "[p]lump your lips, fill in fine lines and wrinldes") under section 201(h) of the Act.
Derma Pens:
Powered LED Microneedling Device Rechargeable Dermapen for Acne and Stretchmarks Removal (Model Number: OB-DL 01)
2
"Reduce the appearance of fine lines and wrinkles, anti-aging."
"For acne / skin inflammation, environment of bacteria, anti-inflammatory."
"Repairing the acne / scar."
"Penetrate the skin deep, accelerate active tissue metabolism decomposition color spots."
"OstarBeauty OB-DL 01 micro dermapen skin needling is great for improving fine lines, wrinkles and sagging or crepe textured skin, the treatments also work to improve acne, pigmentation, scarring (including acne scars), stretch marks and a host of other skin concerns. This is because the process completely rejuvenates the skin with natural new collagen and elastin growth, as well as allowing skin correcting ingredients such as retinols and peptides to penetrate deep into the skin."
Power Microneedling device Anti Backflow LCD Dermapen LED Therapy (Model Number: OB-DL 03) (with 5 level speed from 4000-10000RMP, and needle lengths from 0-2.0mm)
3
"ACNE SCAR Repair damaged skin."
"SKIN LIFTING Introduce the essence to tighten."
Red LED Vibrating Photon 540 600 Needles Microneedling Derma Roller (Model Number: OB-VMN 01)
4
"Ostar derma roller works by using extremely tiny needle to stimulate your skin's collagen productions."
"635nm red led light speed up healing to make muscle and skin cells grow 5 times of normal rate, increase endurance anti-fatigue, promote cell metabolism."
"RED BIO LIGHT — 650-730nm Reduce the appearance of fine, anti-aging."
Claims or statements of penetration or some effect beyond the stratum corneum into living layers of skin by such products show an intent to cure, mitigate, treat or prevent disease or affect the structure or any function of the body. See FD&C Act § 201(h). Based on the claims and statements on your firm's website, the Powered LED Microneedling Device Rechargeable Dermapen for Acne and Stretchmarks Removal, Power Microneedling device Anti Backflow LCD Dermapen LED Therapy, and Red LED Vibrating Photon 540 600 Needles Microneedling Derma Roller are devices because they are intended for use in the "cure, mitigation, treatment, or prevention of disease" or "intended to affect the structure or any function of the body" (e.g., "Reduce the appearance of fines lines and wrinkles, anti-aging," "the treatments also work to improve acne, pigmentation, scarring (including acne scars), stretch marks and a host of other skin concerns," "Repair damaged skin" with a needle length "from 0-2.0mm," and work "by using extremely tiny needle to stimulate your skin's collagen productions") under section 201(h) of the Act.
LED Masks:
Rechargeable Silicone Bendable Gene Biology LED Facial Light Therapy Mask (Model Number: OB-LED 01)
5
"Red light 640-670nm Wrinkle, anti-aging"
"Yellow light 656-570nm Pigment, improve rough skin"
"Purple light 380-440nm Repairing acne, scar"
"Laser light Decomposition color spots"
OstarBeauty Wireless 7 Color LED Light Therapy Facial Mask with Neck (Model Number: OB-LED 02)
6
"RED LIGHT (650-730NM) Reduce the appearance of fine lines and wrinkles, anti-aging."
"BLUE LIGHT (525-550NM) For acne / skin inflammation, environment of the bacteria, anti-inflammatory."
"YELLOW LIGHT (565-570NM) Decompose pigment, improve rough skin, wrinkles,skin [sic] redness."
"PURPLE LIGHT (380-440NM) Repairing the acne / scar."
"LASER LIGHT (SOFT LIGHT) Penetrate the skin deep, accelerate active tissue metabolism decomposition color spots."
"Calm skin and reduce burns of skin after sun exposure."
"Alleviate neck and facial redness and fever for menopausal females."
LED PDT Phototherapy LED Light Beauty Machine for Face and Body Treatment (Model Number: OB-LED 03)
7
"Specific wavelength of bio light penetrates the surface of the skin, penetrates into the fat layer of the skin, stimulates blood circulation in capillaries, regenerates collagen, and achieves skin anti-inflammatory and detoxification effects, thereby improving acne and enhancing skin elasticity."
"RED LIGHT (650-730NM) Reduce the appearance of fine lines and wrinkles, anti-aging."
"BLUE LIGHT (525-550NM) For acne / skin inflammation, environment of the bacteria, anti-inflammatory."
"YELLOW LIGHT (565-570NM) Decompose pigment, improve rough skin, wrinkles, skin [sic] redness."
"PURPLE LIGHT (380-440NM) Repairing the acne / scar."
"LASER LIGHT (SOFT LIGHT) Penetrate the skin deep, accelerate active tissue metabolism decomposition color spots."
Supper Effective 650nm Laser Hair Growth Helmet Cap (Model Number: OB-LL 01N)
8
"650nm laser irradiation, with strong permeability and radiation power, through deep sucutaneous [sic] cells, deep into the root of the hair follicle for cell division and transport nutrients, accelerate the division of hair folliceles [sic],promote rapid growth of hair follices [sic]."
"MULTIPLE FUNCTION Prevent hair loss, fast repair, smoother hair."
"Oil-Control — Balance oil secretion,Create [sic] healthy growing environment"
"Anti-hair Loss — Get hair back to health grow, decrease damaged hair."
"Hair Growth — Reduce hair follicle damage, promote hair growth."
"Hair Care — Promote blood circulation, help to strengthen hair."
Claims or statements of penetration or some effect beyond the stratum corneum into living layers of skin by such products show an intent to cure, mitigate, treat or prevent disease or affect the structure or any function of the body. See FD&C Act § 201(h). Based on the claims and statements on your firm's website, the Rechargeable Silicone Bendable Gene Biology LED Facial Light Therapy Mask, OstarBeauty Wireless 7 Color LED Light Therapy Facial Mask with Neck, LED PDT Phototherapy LED Light Beauty Machine for Face and Body Treatment, and Supper Effective 650nm Laser Hair Growth Helmet Cap are devices because they are intended for use in the "cure, mitigation, treatment, or prevention of disease" or "intended to affect the structure or any function of the body" (e.g., stimulate the body's tissues for purposes, such as "hair growth," improve the appearance of wrinkles and scars, and treat various dermatological conditions, such as acne) under section 201(h) of the Act.
Home Cryolipolysis Fat Freezer Weight Loss Body Shape CryoPad (Model Number: CryoPad)
9
"Mini Cryolipolysis Slimming — Home Use Beauty Machine. Body Slimming. Body Shape. Reduce Fat."
"Working Principle of CryoPad
o  1. Cryolipolysis: As triglyceride in fats will be converted into solid in particular low temperatures, it uses advanced cooling technology to selectively target fat bulges and eliminate fat cells through a gradual process that does not harm the surrounding tissues,reduce [sic] unwanted fat, When fat cells are exposed to precise cooling, they trigger a process of natural removal that gradually reduces the thickness of the fat layer. And The fat cells in the treated area are gently eliminated through the body's normal metabolism process, to eliminate unwanted fat. Precisely controlled cooling is applied through the skin to the fat layer, and eliminate local fat.
o  2. LED Therapy: Wavelength 423nm can be perment into skin 1mm, Anti-inflammatory, antiseptic has good auxiliary function."
Claims or statements of penetration or some effect beyond the stratum corneum into living layers of skin by such products show an intent to cure, mitigate, treat or prevent disease or affect the structure or any function of the body. See FD&C Act § 201(h). Based on the claims and statements on your firm's website, the Home Cryolipolysis Fat Freezer Weight Loss Body Shape CryoPad is a device because it is intended for use in the "cure, mitigation, treatment, or prevention of disease" or "intended to affect the structure or any function of the body" (e.g., applies "cryolipolysis" and "LED therapy" technologies "through the skin to the fat layer," for "body slimming," "body shape," and "reduce fat") under section 201(h) of the Act.
Electroporation Mesotherapy Needle-Free Injection Beauty Machine (Model Number: OB-N 02)
10
"Facial wrinkle removal."
"Repair acne marks."
"OB-N 02 uses Electroporation and Electroosmosis techniques,without [sic] any injectors, easily opens the aquaporin(AQP), transports skin wanted nutrition, so as to treat all kinds of skin problems."
Claims or statements of penetration or some effect beyond the stratum corneum into living layers of skin by such products show an intent to cure, mitigate, treat or prevent disease or affect the structure or any function of the body. See FD&C Act § 201(h). Based on the claims and statements on your firm's website, the Electroporation Mesotherapy Needle-Free Injection Beauty Machine is a device because it is intended for use in the "cure, mitigation, treatment, or prevention of disease" or "intended to affect the structure or any function of the body" (e.g., applies energy to the skin and uses "Electroporation and Electroosmosis techniques" for "facial wrinkle removal" and "repair acne marks") under section 201(h) of the Act.
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA (see 21 CFR 807.20(a)). In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1' and ending December 31' of each year. As of this date, our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2023.
Therefore, the listed devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360), and the devices were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
Given the serious nature of the violations of the Act, 3 Levels Injection Insulin Gun Hyaluronic Acid Skin Injection Needle Free Pen, Powered LED Microneedling Device Rechargeable Dermapen for Acne and Stretchmarks Removal, Power Microneedling device Anti Backflow LCD Dennapen LED Therapy, Red LED Vibrating Photon 540 600 Needles Microneedling Derma Roller, Rechargeable Silicone Bendable Gene Biology LED Facial Light Therapy Mask, OstarBeauty Wireless 7 Color LED Light Therapy Facial Mask with Neck, LED PDT Phototherapy LED Light Beauty Machine for Face and Body Treatment, Supper Effective 650nm Laser Hair Growth Helmet Cap, Home Cryolipolysis Fat Freezer Weight Loss Body Shape CryoPad, and Electroporation Mesotherapy Needle-Free Injection Beauty Machine, are devices subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as "detention without physical examination," until these violations are addressed. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and address the violations described in this letter. We will notify you regarding the adequacy of your firm's response and the need to inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm's response should be sent by email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Refer to CMS case #667871 when replying.
If you have any questions about the contents of this letter, please contact:
DHT4A Acting Assistant Director, Mark Trumbore
at 301-796-5436 or (301) 595-7851.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your film should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
Sincerely yours,
/S/
Binita Ashar, MD
Director
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
____________________
1
https://www.ostarbeauty.com/shop/chinese-supplier-3-levels-hyaluronic-acid-skin-injection-needle-free-pen.
2
https://www.ostarbeautv.com/shop/led-microneedle-pen-rechargeable-dertnapen-for-acne-and-stretchmarks-removal.
3
https://www.ostarbeauty.com/shop/advanced-technology-anti-backflow-lcd-dermapen-microneedle-led-therapy.
4
https://www.ostarbeauty.com/shop/red-led-vibrating-photon-540-600-needles-microneedling-derma-roller.
5
https://www.ostarbeautv.com/shop/ostarbeauty-effective-led-gene-biology-best-led-face-light-theravy-mask.
6
https://www.ostarbeauty.com/shop/ostarbeauty-wireless-7-color-led-light-therapy-facial-mask-with-neck.
7
https://www.ostarbeautv.com/shop/led-pdt-phototherapy-led-light-beautv-machine-for-face-and-bodv-treatment.
8
https://www.ostarbeautv.com/shop/supper-effective-650nm-laser-hair-growth-helmet-hair-growth-hat-cap.
9
https://www.ostarbeatity.conilshop/professional-home-use-weight-loss-cryolipolysis-fat-freezer-cryopad-slimming-machine.
10
https://www.ostarbeauty.com/shop/electroporation-no-needle-mesotherapy-needle-free-injection-beauty-machine.
Content current as of:
05/28/2024
Regulated Product(s)
Medical Devices