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Silicone Hydrogel For Scar Management

Page Type
Product Code
Definition
Management of closed hyperproliferative (hypertrophic and keloid) scars.
Physical State
Silicone oil containing hydrogel with preservative identified by the Center for Drug Evaluation and Research (CDER) as an inactive ingredient.
Technical Method
Product forms a protective film that helps maintain skin hydration.
Target Area
Scars on the skin
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4025
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4025 Silicone sheeting

§ 878.4025 Silicone sheeting.

(a) Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

[69 FR 48148, Aug. 9, 2004]

Silicone Hydrogel For Scar Management

Page Type
Product Code
Definition
Management of closed hyperproliferative (hypertrophic and keloid) scars.
Physical State
Silicone oil containing hydrogel with preservative identified by the Center for Drug Evaluation and Research (CDER) as an inactive ingredient.
Technical Method
Product forms a protective film that helps maintain skin hydration.
Target Area
Scars on the skin
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4025
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4025 Silicone sheeting

§ 878.4025 Silicone sheeting.

(a) Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

[69 FR 48148, Aug. 9, 2004]