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WARNING LETTER

Marci Beauty LLC MARCS-CMS 612041 —

Product:
Medical Devices

Recipient:
Recipient Name
Shaul Rappaport
Recipient Title
Product Manager
Marci Beauty LLC

8000 W Badura Ave., Unit 1148
Spring Valley, NV 89113
United States

Shaul@spacetouch.com
Issuing Office:
Center for Devices and Radiological Health

United States


WARNING LETTER

February 2, 2021

Re: Jupiter, Vega, Neptune, Luna, Cosmo, Nova, Galaxa
Refer to CMS# 612041

Dear Mr. Shaul Rappaport:

The United States Food and Drug Administration (FDA) has learned that your firm is marketing the following light therapy devices in the United States without marketing clearance or approval:
􀁸 Jupiter
􀁸 Vega
􀁸 Neptune
􀁸 Luna
􀁸 Cosmo
􀁸 Nova
􀁸 Galaxa

Under section 201(h) of the Act, 21 U.S.C. § 321(h) of the Federal Food, Drug, and Cosmetic Act (Act), 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 to affect the structure or any function of the body.

A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. FDA has reviewed your firm’s website www.spacetouch.com on February 2, 2021 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 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The devices listed above are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Our review of your firm’s website at www.spacetouch.com determined your firm is making intended use claims which cause the products to be medical devices under section 201(h) of the Act. These claims include, but are not limited to:

  • Jupiter:

o “WHAT JUPITER TARGETS: WRINKLES & LINES | … | PIGMENTATION | ACNE | . . . .”
o “The Blue Light technology is used to treat sun damage and to prevent skin cancer growth. It has also been shown to help with acne, sun spots, and even acne scarring.”

  • Vega:

o “WHAT VEGA TARGETS: . . . | ECZEMA | ROSACEA | . . . .”
o “The Amber Light technology is used to treat skin redness and flushing, irritation, rosacea, UV radiation damage. . . . It helps to flush waste from the skin, boost lymphatic flow, and increase cellular growth.”

  • Neptune:

o “WHAT NEPTUNE TARGETS: SUN SPOTS | ACNE | … PIGMENTATION | DARK CIRCLES | . . . .”
o “The Blue Light technology is used to treat sun damage and to prevent skin cancer growth. It has also been shown to help with acne, sun spots, and even acne scarring.”

  • Luna:

o “Luna increases bone density and treats skin disorders, certain cancers and precancers, mood and sleep disorders, hyperbilirubinemia and jaundice, and more”
o “Luna is the only home-use device to feature Calcium Supplementation light therapy which combines UVB and LED bulbs to promotes good cholesterol, increases bone mineral density, and treats osteoporosis, cartilage diseases, and dysplasia. It also prevents complications caused by the abnormal metabolism of calcium and phosphorus ions.”
o “WAVELENGTH GUIDE:

Penetration Depth Of 635 nm:
1. Tackles inflammation
2. Acts as an analgesic
3. Prevents retention of fluid
4. Treats clinical neurodermatitis
5. Treats acne
. . . .
Penetration Depth Of 415 nm:
1. Synthesizes protein and bone collagen
2. . . . Helps with neonatal jaundice
. . . .
5. Clinically treats goiter
6. Treats chronic heart disease
7. Treats insomnia
8. Relieves menopausal syndrome

Penetration Depth Of 560 nm:
1. Treats asthma
2. Treats Climacteric Syndrome and endocrine disorders
3. Decreases nerve numbness
4. Treats kidney and digestive tract diseases
5. Treats symptoms of Diabetes
6. Eliminates endotoxins
7. Treats rough skin
8. Decreases wrinkles, including those caused by stress and fatigue
9. Removes acne, including blackheads

Penetration Depth Of 590 nm:
1. Inhibits skin melanin
2. Accelerates wound and ulcer healing
3. Increases secretion of adrenaline
4. Clinically stimulates the heart
5. Clinically dilates the trachea associated with asthma

Penetration Depth Of 610 nm:
1. Stimulates secretory system
2. Drains lymph glands
3. Treats skin and mucosal ulcers
4. Treats acne

Penetration Depth Of 540 nm:
1. Accelerates metabolism
. . . .
3. Treats emaciation and anemia
4. Clinically treats general heart disease, especially weak heartbeat”

  • Cosmo:

o “[I]t’s stocked with the newest LED technologies to treat issues like cellulite, stretch-marks, sun damage, spider veins, acne, and more.”
o “One device for all: cellulite, acne, spider veins, sore muscles, slimming, stretch marks”
o “RED+INFRA RED 640-876 NM 1-6 MM DEEP:
. . . .
􀆔 Increases the production of collagen and elastic fibers
. . . .
􀆔 Increases cell life, including deep cell energy replenishment
. . . .
YELLOW+INFRA RED 583-730 NM 1-2 MM DEEP:
􀆔 Helps to treat pigmented lesions, wrinkles, and fine plaques
􀆔 Detoxes cells and eliminates edema
. . . .
BLUE+INFRA RED 423-823 NM 1 MM DEEP
􀆔 Helps to reduce acne
􀆔 Kills sebaceous glands to prevent scars caused by acne
. . . .
􀆔Brightens pigmentation
GREEN+INFRA RED 532-852 NM 0.5-2 MM DEEP
. . . .
􀆔 Helps with skin redness, rosacea, and spider veins”

  • Nova:

o “HI-TECH SKIN MASK SERIES: WRINKLES | PIGMENTATION | LIFTING”
o “nova stimulates the cells under your skin boosting the production of natural collagen”
o “NOVA IS A POWERFUL, NON-INVASIVE FACE MASK DEVICE THAT REDUCES WRINKLES, EVENS PIGMENTATION AND INVIGORATES YOUR SKIN.”

o “PENETRATION DEPTH OF 640NM: Stimulates collagen production . . . .

PENETRATION DEPTH OF 415NM: Kills bacteria, whitens skin, treats acne and scarring.

PENETRATION DEPTH OF 580NM: Manages smaller traces of skin problems like wrinkles or discoloration.”

  • Galaxa:

o “FOR BODY AND FACE.: CELLULITE | ACNE | SPIDER VEINS | STRETCH MARKS | … | AGE SPOTS”
o “Instead of heading to a doctor’s office to receive inconvenient and expensive treatments, you can use Galaxa. It’s clinically certified as safe on all parts of the body and treats a variety of skin issues including cellulite, spider veins, discoloration, acne, scars, and sagging skin.”

Please note this is not an exhaustive list. We also note that some of these indications of treating serious life-threatening diseases, such as cancers, dysplasia, hyperbilirubinemia and jaundice, osteoporosis, heart disease, kidney and digestive tract diseases, emaciation and anemia, etc., have not been verified with any clinical data in an FDA marketing application of this device type. These claims could mislead patients and result in the delay or substitution of critical medical treatment, thereby posing further health risks.

On June 17, 2020, we sent you an “It Has Come to Our Attention” letter, requesting that you provide the FDA with either clearance or approval submission number(s) for the devices listed above. We have reviewed your firm’s response, dated July 23, 2020, and determined it is not adequate. Your firm’s response states that: “We currently manufacture our devices in China. Factory name: Zhongshan Bisen Plastic Electronic products co. LTD.” You also provided the substantial equivalence determination letter for K162489, for RED Light Device by Zhongshan Bisen Plastic Electronic Products Co., Ltd. However, we have reviewed our records and determined that the FDA cleared RED Light Device is not related to any of the devices being marketed by Marci Beauty LLC on www.spacetouch.com. Moreover, the RED Light Device was cleared under K162489 with the following indications: “The RED Light Device is an OTC device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.” However, the devices marketed by your firm have various indications and device designs that are different from and outside the scope of the clearance for the RED Light Device. Your firm’s products, as described above, meet the definition of a device as defined in section 201(h) of the Act and are subject to all applicable statutory and regulatory requirements.

Therefore, the devices listed above are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because 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 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) of the Act, 21 U.S.C. § 360(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://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our office requests that Marci Beauty LLC cease any activities that result in the misbranding or adulteration of the devices listed above, such as the commercial distribution of the devices for the uses discussed above.

Your firm should take prompt action to address any violations described in this letter. Failure to adequately address this matter may lead to regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, other federal agencies may take your compliance history into account when considering the award of 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 any violations, as well as 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) 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. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. Please provide a translation of documentation not in English to facilitate our review.

Your firm’s response should be sent 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 the identification number CMS# 612041 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Purva Pandya at 240-402-9979.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.

Sincerely yours,
/S/

Binita S. Ashar, MD, MBA, FACS
Director
OHT 4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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