510(k) K870790

REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000 by Lifestream Int'L, Inc. — Product Code FTX

K870790 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000". The FDA issued a decision of Substantially Equivalent on April 1, 1987. The device falls under product code FTX (Mirror, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1987
Date Received
February 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mirror, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type