FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9

K Number: K852534 · Decision Nov 8, 1985
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
271
Applicant Total
13
Review Days
147

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Basic Information

Device Name
ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9
K Number
K852534
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4630
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
R. A. Fischer Co. Corp.
Date Received
June 14, 1985
Decision Date
November 8, 1985
Product Code
FTC
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
FTC Light, Ultraviolet, Dermatological

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Other Clearances by R. A. Fischer Co. Corp.

K Number Device Name
K964208 MD-1A GALVANIC UNIT
K954031 COMPU-BLEND EPILATOR
K895365 MD-2 IONTOPHORESIS UNIT
K893389 MODEL SE-5 EPILATOR
K884079 MODEL CBX EPILATOR
K871372 CB-7 ELECTRONIC EPILATOR
K843063 ELECTRONIC EPILATOR TS-1
K823674 HIGH FREQUENCY EPILATOR CB-2
K801351 EPILATOR, MODEL CP-16
K780076 EPILATOR, ELECTRONIC MODEL SE-2
Search all 13 clearances from R. A. Fischer Co. Corp. →