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510(k) Data Aggregation
K Number
K233099Device Name
Gladiator
Manufacturer
Rohrer Aesthetics, LLC
Date Cleared
2024-05-22
(239 days)
Product Code
GEI, GEX, IMG, OUH
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Rohrer Aesthetics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gladiator system contains three handpieces, each of which has its own indications for use.
The PiXel8-RF handpiece is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostatis.
The Bodysculp laser lipolysis handpiece intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive a desired a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
The Body Tone handpiece is intended for Relaxation of muscle spasms, Prevention or disuse atrophy, Increasing local blood circulation. Muscle re-education. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
Device Description
The Gladiator is a multi-function system that combines RF Microneedling, Low Level Laser and Electronic Muscle Stimulation (EMS) technologies into a single console. The system is intended for dermatologic and general surgery purpose as well as pain relief. The system is comprised of a single console with three handpieces:
- PiXel8-RF - a bipolar radiofrequency micro needling handpiece with disposable tips
- . BodySculp - a low level laser
- . BodyTone (previously called Futura Pro) – an electronic muscle stimulator
The system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source.
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K Number
K212331Device Name
BodySculp
Manufacturer
Rohrer Aesthetics, LLC
Date Cleared
2021-11-09
(105 days)
Product Code
PKT
Regulation Number
878.5400Why did this record match?
Applicant Name (Manufacturer) :
Rohrer Aesthetics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bodysculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic assthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
Device Description
The BodySculp is a diode laser system. The main components of BodySculp are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which issued to deliver laser energy to subcutaneous tissue layers.
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K Number
K210535Device Name
UltraLight LED System
Manufacturer
Rohrer Aesthetics, LLC
Date Cleared
2021-05-24
(89 days)
Product Code
GEX, OLI
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Rohrer Aesthetics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LED red light: The UltraLight" is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The UltraLight" is also indicated for use in dermatology for the treatment of superficial, benign vascular, and pigmented lesions.
LED blue light: The UltraLight" is indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
LED green light: The UltraLight "green Light" is indicated for use as a non-invasive dermatological aestheic treatment for the reduction of circumference of hips, waist, and thighs.
Device Description
The UltraLight LED System is a low level laser system for aesthetic use. The device can emit three different wavelengths (i.e., red light @ 633 nm, blue light @ 415 nm, and green light @ 532 nm) to achieve its intended purpose. All three wavelengths have different indications for use. The device works by illuminating the skin with a single wavelength of red, blue, or green light. The device utilizes a 28.8cm X 38.0 cm irradiation board to deliver light directly to the desired target. The device is activated and controlled through the LCD control panel.
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K Number
K192583Device Name
PicoLazer Laser System
Manufacturer
Rohrer Aesthetics, LLC
Date Cleared
2020-01-17
(120 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Rohrer Aesthetics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PicoLazer laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm
The 1064 nm wavelength of the PicoLazer laser system is indicated for:
- treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
- tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)
532 nm
- The 532 nm wavelength of the PicoLazer laser system is indicated for:
- treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
- tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
Device Description
The Rohrer Aesthetics, LLC PicoLazer™ laser system is a dual-wavelength (532 and 1064 nm) Nd:YAG laser system that offers a 450-picosecond pulse duration that produces a maximum energy of 500mJ at 1064nm and 250mJ at 532nm.
The PicoLazer laser system consists of a system console, an articulated arm, a laser handpiece, a footswitch, and a remote interlock plug. Other components necessary for operation, such as power cables, are also included.
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K Number
K191162Device Name
EpiLaze Multi-wavelength Laser
Manufacturer
Rohrer Aesthetics, LLC
Date Cleared
2019-07-09
(69 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Rohrer Aesthetics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use:
The EpiLaze Multi-wavelength Laser is intended for use in dermatologic and general surgical procedures.
Indication for Use for the 1064nm wavelength:
- The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) Modes are intended for
- permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen: and
- treatment of Pseudo folliculitis Barbae (PFB).
Indication for Use for the 810nm wavelength:
- The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) . Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Indication for use for the 755nm wavelength:
- The Standard Hair Removal (STANDARD) and Smooth Flow Technology Hair Removal (SFT) ● Modes are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
The STANDARD mode can be used on all skin types (Fitzpatrick I-VI), including tanned skin. The SFT mode can only be used on Fitzpatrick skin type I-IV. Do not use the SFT mode on tanned skin.
Device Description
The EpiLaze Multi-wavelength Laser is a microprocessor-controlled, user friendly 755nm, 810nm and 1064nm Diode laser system using a sealed diode pack that produces a maximum energy of 120J/cm². The system incorporates a diode pack within each hand piece, and the energy is delivered from the hand piece directly to the desired target. The EpiLaze Multi-wavelength Laser consists of a console, a touch screen user interface, a footswitch and 2 handpieces
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K Number
K180654Device Name
PINXEL-RF system
Manufacturer
Rohrer Aesthetics, LLC
Date Cleared
2018-07-13
(122 days)
Product Code
GEI, OUH
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Rohrer Aesthetics, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PINXEL-RF system is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
The PINXEL-RF System includes the system main body, a bipolar handpiece with disposable micro-needle type electrodes, a footswitch and an LCD touch screen control panel. The RF energy is delivered to a target tissue using a handpiece and disposable tip (micro needle electrode tip), the tip being placed in light contact with the tissue and the handpiece being held at right angles to the target tissue. As the RF energy passes through the tissue, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the micro needle tip, the PinXel system creates heat within the target tissue via micro- needles inserted from the tip.
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