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Gas, Laser Generating

Page Type
Product Code
Definition
Special laser gas mixtures used as a lasing medium
Physical State
Special laser gas mixtures used as a lasing medium
Technical Method
Special laser gas mixtures used as a lasing medium
Target Area
Special laser gas mixtures used as a lasing medium
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4810
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]

Gas, Laser Generating

Page Type
Product Code
Definition
Special laser gas mixtures used as a lasing medium
Physical State
Special laser gas mixtures used as a lasing medium
Technical Method
Special laser gas mixtures used as a lasing medium
Target Area
Special laser gas mixtures used as a lasing medium
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4810
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]