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Lipoaspirate Washing System For Aesthetic Body Contouring

Page Type
Product Code
Definition
Wash autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further processing/manipulation.
Physical State
May include filter, sieve, canister, non-enzymatic wash solution, non-suctioning. The system should be used with a legally-marketed vacuum or aspirator apparatus as a source of suction. Should not use enzymatic digestion or cell selection.
Technical Method
Aspirated fat is washed, cleansed, and/or rinsed without further processing/manipulation such as cell selection or enzymatic digestion.
Target Area
Aesthetic body contouring of soft tissues
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.5040
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.5040 Suction lipoplasty system

§ 878.5040 Suction lipoplasty system.

(a) Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of

1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.

(b) Classification. Class II (special controls). Consensus standards and labeling restrictions.

[63 FR 7705, Feb. 17, 1998]

Lipoaspirate Washing System For Aesthetic Body Contouring

Page Type
Product Code
Definition
Wash autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further processing/manipulation.
Physical State
May include filter, sieve, canister, non-enzymatic wash solution, non-suctioning. The system should be used with a legally-marketed vacuum or aspirator apparatus as a source of suction. Should not use enzymatic digestion or cell selection.
Technical Method
Aspirated fat is washed, cleansed, and/or rinsed without further processing/manipulation such as cell selection or enzymatic digestion.
Target Area
Aesthetic body contouring of soft tissues
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.5040
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.5040 Suction lipoplasty system

§ 878.5040 Suction lipoplasty system.

(a) Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of

1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.

(b) Classification. Class II (special controls). Consensus standards and labeling restrictions.

[63 FR 7705, Feb. 17, 1998]