Search Results
Found 5 results
510(k) Data Aggregation
K Number
K161502Device Name
MC1 Plus
Manufacturer
GENERAL PROJECT S.R.L.
Date Cleared
2016-08-16
(76 days)
Product Code
IMI
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
GENERAL PROJECT S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MC1 Plus is indicated for:
a) Therapeutic Massager:
1. Provides temporary relief of minor muscle aches and pains;
2. Relieves muscle spasms;
3. Temporarily improves local blood circulation;
4. Temporarily reduces the appearance of cellulite.
b) Ultrasonic Diathermy:
1. Relief of pain;
2. Muscle spasms;
3. Joint contractures;
4. NOT for the treatment of malignancies.
Device Description
MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.
Ask a Question
K Number
K091615Device Name
MED CONTOUR
Manufacturer
GENERAL PROJECT S.R.L.
Date Cleared
2010-05-06
(337 days)
Product Code
IMI, ISA
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
GENERAL PROJECT S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MC1 is indicated for: a) Therapeutic Massager: 1. Provides temporary relief of minor muscle aches and pains; 2. Relieves muscle spasms, 3. Temporarily improves local blood circulation; 4. Temporarily reduces the appearance of cellulite. b) Ultrasonic Diathermy: 1. Relief of pain; 2. Muscle spasms; 3. Joint contractures; 4. NOT for the treatment of malignancies.
Device Description
The MC1 is a computerized body massager and ultrasound diathermy system. The MC1 is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massage.
Ask a Question
K Number
K062312Device Name
AXIOM PULSED LIGHT SYSTEM
Manufacturer
GENERAL PROJECT S.R.L.
Date Cleared
2006-10-16
(69 days)
Product Code
GEX, PAN
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GENERAL PROJECT S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. It is intended for use in:
- Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction
- Treatment of mild to moderate inflammatory acne (acne vulgaris) .
- Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and cafè-au-lait
Device Description
The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 mm to 1200 mm. The Axion Intense Fullood Eight Oyel Cyell is based on a quick power discharge of Capacitors in a Xenon ramp, mountou on a hanspires include the charge intense Fulsed Eight. The four philopal pairol panel, and a handpiece with exchangeable lamp box
Ask a Question
K Number
K053041Device Name
MED SCULPT
Manufacturer
GENERAL PROJECT S.R.L.
Date Cleared
2006-08-02
(279 days)
Product Code
IMI, ISA
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
GENERAL PROJECT S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is indicated for:
a. Therapeutic Massager:
i. Provides temporary relief of minor muscle aches and pains . -
ii . Relieves muscle spasms
iii. Temporarily improves local blood circulation
iv. Temporarily reduces the appearance of cellulite
b. Ultrasonic Diathermy:
i. Relief of pain
ii. Muscle spasms
III. Joint contractures
iv. NOT for the treatment of malignancies
Device Description
The MED SCULPT Computerized Body Massager and M-Sonic Ultrasound Diathermy system has massage and ultrasound diathermy components. The massage portion of the device uses a specially designed membrane, made up of elastomeric material. This membrane, fastened onto the handbiece, moves in an alternate way due to changeable depression created by a vacuum pump; such movement is due to the opening and closing of two electronically controlled electrovalves. The unit also includes an ultrasonic handpiece that can be used to perform ultrasound diathermy. Ultrasound is a particular form of mechanical energy which leads to an increase in the molecular vibration of the tissue resulting in heat generation and according to this principle the ultrasonic handpiece of the unit, using an ultrasound wave at the fixed frequency of 3 MHz, produces thermal changes in the areas of the body where it is applied.
Ask a Question
K Number
K051508Device Name
MED FLASH II INTENSE PULSED LIGHT SYSTEM.
Manufacturer
GENERAL PROJECT S.R.L.
Date Cleared
2005-10-05
(120 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GENERAL PROJECT S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MED flash II Intense Pulsed Light System is indicated for use in:
- Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction
- Treatment of inflammatory acne (acne vulgaris)
- Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and café-au-lait
- Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins
- The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.
Device Description
The MED flash II Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. The system is based on a quick power discharge of capacitors in a Xenon lamp, mounted on a handpiece. This generates a rapid and Intense Pulsed Light.
The Med flash II system contains five principal components:
- Charge system of the capacitors .
- Electronic control system .
- Control panel .
- Handpiece with exchangeable lamp box ●
- Handpiece cooling system .
Ask a Question
Page 1 of 1