Surgilase, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K932421SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASEOctober 15, 1993
K924664SURGILASE FIBERLASE CO2 LASER WAVEGUIDEApril 15, 1993
K905006SURGILASE SL 150 SURGICAL LASER SYSTEMFebruary 21, 1991
K904203SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEMDecember 7, 1990
K902211SURGILASE YAG 100 SURGICAL LASER SYSTEMJune 29, 1990
K900570SURGILASE YAG 100 IN ORTHOPEDIC SURGERYMay 1, 1990
K901227SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL120April 26, 1990
K901211SURGILASE SL50 SURGICAL LASER SYSTEMApril 26, 1990
K894471SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERYNovember 14, 1989
K894396SURGILASE 25, 40, 45, 55, 60, 80, 100 LASERAugust 7, 1989
K891461SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURGApril 6, 1989
K884182SURGILASE YAG 100 SURGIPROBES & SURGISCALPELJanuary 24, 1989
K884313MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMSOctober 27, 1988
K884311MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMSOctober 27, 1988
K884092SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80October 13, 1988
K875042ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARYJune 24, 1988
K881499SURGILASE YAG 100 FOR GYNECOLOGY USEApril 29, 1988
K875039ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGYApril 13, 1988
K852470SURGILASE 40SNovember 13, 1985