Last synced on 2 December 2022 at 11:04 pm

Transparent Patch For Use In Treatment Of Tattoos

Page Type
Product Code
Definition
To reduce formation of bubbles during laser treatment of tattoos.
Physical State
Liquid in a transparent double sided silicon patch
Technical Method
Uses a chemical optical clearing agent to interact with the bubbles as they are attempting to form to prevent this formation.
Target Area
tattoos
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4810
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a) Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

(b) Classification. (1) Class II.

(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]

Transparent Patch For Use In Treatment Of Tattoos

Page Type
Product Code
Definition
To reduce formation of bubbles during laser treatment of tattoos.
Physical State
Liquid in a transparent double sided silicon patch
Technical Method
Uses a chemical optical clearing agent to interact with the bubbles as they are attempting to form to prevent this formation.
Target Area
tattoos
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4810
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a) Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

(b) Classification. (1) Class II.

(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]