(90 days)
The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece are intended for soft tissue indications (CO, soft tissue clearances previously obtained by Heraeus Surgical). In addition, indications include treatment of wrinkles/rhytides; solar/actinic elastosis; lentigos; laser skin resurfacing; laser resurfacing; laserbrasion; scar revision; warts; periorbital syringomas; epidermal nevi; rhinophyma; xanthelasma; actinic cheilitis and debulking benign tumors.
- ParaScan™ Scanning Device A.
- CBH-1 Collimated Beam Handpiece B.
This document does not contain information about acceptance criteria or a study proving a device meets them. The provided text is a summary of safety and effectiveness for a medical device called ParaScan Scanning Device or CBH-1 Collimated Beam Handpiece, focusing on its regulatory classification, indications for use, and comparison with a predicate device. It does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.
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964520 . FEB 10 1997
SUMMARY OF SAFETY AND EFFECTIVENESS PARASCAN SCANNING DEVICE OR CBH-1 COLLIMATED BEAM HANDPIECE FOR TREATMENT OF WRINKLES/RHYTIDES
REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Lisa McGrath Sr. Regulatory Affairs Specialist Laserscope 3052 Orchard Parkway San Jose, CA 95134-2011 (408) 943-0636 (408) 943-1454 FAX
DEVICE TRADE NAME:
- ParaScan™ Scanning Device A.
- CBH-1 Collimated Beam Handpiece B.
DEVICE COMMON NAME:
- A. Scanning Laser Delivery System
- B. Collimated Handpiece
Heraeus Surgical, Inc., including the LaserSonics product line, was Note: acquired by Laserscope.
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SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2
DEVICE CLASSIFICATION:
CO, laser systems have been classified as Class II (79 GEX) medical devices by the OB/GYN. General, Plastic Surgery and ENT Device Advisory Panels. To the best of our knowledge, scanning laser delivery systems and handpiece accessories have not been classified.
PERFORMANCE STANDARDS:
The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.
INDICATIONS FOR USE STATEMENT:
The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece are intended for soft tissue indications (CO, soft tissue clearances previously obtained by Heraeus Surgical). In addition, indications include treatment of wrinkles/rhytides; solar/actinic elastosis; lentigos; laser skin resurfacing; laser resurfacing; laserbrasion; scar revision; warts; periorbital syringomas; epidermal nevi; rhinophyma; xanthelasma; actinic cheilitis and debulking benign tumors.
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SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 3
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COMPARISON WITH PREDICATE DEVICE:
The ParaScan Scanning Device was determined substantially equivalent by FDA on February 13, 1996 for all previously cleared LaserSonics CO, soft tissue surgical applications (510(k)955734). The CBH-1 Collimated Beam Handpiece is equivalent to the ParaScan Scanning Device beam collimator and handpiece.
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§ 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.