Medical Device Manufacturer · US , Allendale , NJ

Sharplan Lasers, Inc. - FDA 510(k) Cleared Devices

78 submissions · 78 cleared · Since 1986
78
Total
78
Cleared
0
Denied
78 devices
51-75 of 78
Cleared Sep 27, 1989
SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERY
K895042 · GEX
General & Plastic Surgery · 49d
Cleared Aug 10, 1989
SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX
K894066 · GEX
General & Plastic Surgery · 63d
Cleared Aug 10, 1989
SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS
K894210 · GEX
General & Plastic Surgery · 52d
Cleared Aug 10, 1989
SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS
K894211 · GEX
General & Plastic Surgery · 52d
Cleared Jun 21, 1989
SHARPLAN 1075 CO2 LASER
K893206 · GEX
General & Plastic Surgery · 56d
Cleared Apr 12, 1989
SHARPLAN MODEL 1050 SEALED-OFF CO2 SURGICAL LASER
K890287 · GEX
General & Plastic Surgery · 83d
Cleared Apr 05, 1989
SHARPLAN MODEL 750 REMOTE CONTROL UNIT (RCU)
K890286 · GEX
General & Plastic Surgery · 76d
Cleared Mar 17, 1989
MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE
K891088 · GEX
General & Plastic Surgery · 71d
Cleared Mar 13, 1989
SHARPLAN MODEL 2106
K891016 · GEX
General & Plastic Surgery · 13d
Cleared Feb 14, 1989
MODIFIED LABELING & PACKAGING OF SHARPLAN 2100
K890040 · GEX
General & Plastic Surgery · 40d
Cleared Feb 06, 1989
SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749
K890059 · GEX
General & Plastic Surgery · 31d
Cleared Dec 15, 1988
SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP
K884994 · GEX
General & Plastic Surgery · 14d
Cleared Oct 14, 1988
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
K883091 · LFL
General & Plastic Surgery · 84d
Cleared Sep 27, 1988
SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS
K883563 · GEX
General & Plastic Surgery · 39d
Cleared Jun 20, 1988
SHARPLAN MEDILAS 4060 N
K882037 · GEX
General & Plastic Surgery · 35d
Cleared Jun 03, 1988
SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI.
K881952 · GEX
General & Plastic Surgery · 24d
Cleared Jun 03, 1988
SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU
K881953 · GEX
General & Plastic Surgery · 24d
Cleared Jun 02, 1988
MODIFIED SHARPLAN MODEL 1020 CO2 LASER
K882180 · GEX
General & Plastic Surgery · 30d
Cleared May 24, 1988
SHARPLAN ND:YAG SURGICAL HAND APPLICATORS
K881870 · GEX
General & Plastic Surgery · 21d
Cleared May 13, 1988
SHARPLAN 719Y MICROSLAD(TM)
K881887 · GEX
General & Plastic Surgery · 8d
Cleared May 11, 1988
MODIFIED MODEL 2100 ND:YAG LASER
K881848 · GEX
General & Plastic Surgery · 9d
Cleared Apr 21, 1988
CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO
K881010 · HET
Obstetrics & Gynecology · 42d
Cleared Apr 14, 1988
MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE
K880193 · LNK
Gastroenterology & Urology · 86d
Cleared Apr 14, 1988
MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE
K880256 · LNK
Gastroenterology & Urology · 85d
Cleared Nov 16, 1987
MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
K871579 · HHR
Obstetrics & Gynecology · 207d

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