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Powered Light Based Non-Laser Surgical Instrument

Page Type
Product Code
Definition
A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
Physical State
The device comes in a wide verity of shapes and sizes. It could be hand held and with weight less than one pound or it could be heavy with weight more than fifty pounds. It generally has a base station with attachments such as different hand piece(s) and touch tone/display screen or other mechanical buttons for user interactions
Technical Method
This is a powered light based but non-laser instrument that uses light energy to destroy or coagulate tissue, generally soft tissue.
Target Area
The device generally targets skin (including dermis, epidermis) and underlying soft tissue or soft tissue in general.
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
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]

Powered Light Based Non-Laser Surgical Instrument

Page Type
Product Code
Definition
A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
Physical State
The device comes in a wide verity of shapes and sizes. It could be hand held and with weight less than one pound or it could be heavy with weight more than fifty pounds. It generally has a base station with attachments such as different hand piece(s) and touch tone/display screen or other mechanical buttons for user interactions
Technical Method
This is a powered light based but non-laser instrument that uses light energy to destroy or coagulate tissue, generally soft tissue.
Target Area
The device generally targets skin (including dermis, epidermis) and underlying soft tissue or soft tissue in general.
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
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]