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DEVICE DETAILS

NAME OF DEVICESKYPULSE
ESTABLISHMENT NAMEVENUSYS MEDICAL SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC6239524-179855
BRAND NAMEFOTONA
MEDICAL DEVICE CATEGORYMD 1402 - Devices utilising non-ionizing radiation
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe SkyPulse laser system family consists of two different versions: • SkyPulse M321-A abbreviated as SkyPulse Versa / Endo Pro which has XS-A Er:YAG laser module and offers water spray for cooling the treated area or Endo Plus which can have XS- A or XSC Er:YAG laser module and also offers water spray for cooling the treated area. • SkyPulse M321-B abbreviated as SkyPulse Endo which has XSB Er:YAG laser module and does not offer water spray for cooling the treated area.
DEVICE INTENDED PURPOSEThe device and its accessories are intended to be used in dentistry, aesthetics, dermatology, ENT, surgery and pain management.
VALIDITY DATE OF REGISTRATION17/08/2024 - 16/08/2029

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Skypulse (M321-A)101033
2Handpiece HC02-N90669
3Handpiece HC14-N90668
4Handpiece HC14-NS95734
5Handpiece HC14-NE103740
6Handpiece R1790039
7Handpiece R21-C390011
8Handpiece R24-S105629
9Handpiece Genova102631
10Handpiece MarcCo S104563
11Handpiece MarcCo M104283
12Handpiece MarcCo L104560
13Cylindrical Sapphire 1300/871766
14Cylindrical Sapphire 1300/1272558
15Conical Sapphire 600/872937
16Flat Chiseled 500/1272561
17Radial, Sweeps 400/1490333
18Radial, Sweeps 600/1490334
19Conical Sapphire 800/872560
20Conical Sapphire 800/1272856
21Flat Sweeps 300/2083890
22Flat Sweeps 400/1484827
23Flat Varian 500/1484837
24Flat Varian 600/984838
25Flat Varian 600/1484839
26Conical Sapphire 600/1099128
27Conical Sapphire 600/1272857
28Conical Sapphire 600/1685830
29Flat Sweeps 300/9102037
30Flat Sweeps 400/984826
31Radial Sweeps 400/9102036
32Flat Varian 500/984836
33Radial, Sweeps 600/9102135
34Thin Chisel 150/12110325
35Cylindrical Sapphire 1000/4112782
36Cylindrical Sapphire 1000/8112781
37Cylindrical Sapphire 1000/12112779
38Radial Sweeps 400/1490333
39Radial Sweeps 600/1490334
40Flat Sweeps 300/2083890
41Flat Sweeps 400/1484827
42Conical Sapphire 600/1099128
43Flat Sweeps 300/9102037
44Flat Sweeps 400/984826
45Radial Sweeps 400/9102036
46Radial, Sweeps 600/9102135
47Thin Chisel 150/12110325
48Cylindrical Sapphire 1000/4112782
49Cylindrical Sapphire 1000/8112781
50Laser module LM XS-A101468
51Laser module LM XS-B101469
52Laser module LM XS-C106020
53Laser module LM XS-AF110664
54Laser module LM XS-BF110665
55Laser module LM XS-CF110666
56Laser module LM XD-10102821
57Laser module LM XD-10/19102824
58Laser module LM XD-67/10102825
59Laser module LM XD-67/80/10F108970
60Trolley SkyPulse103240
61Trolley SkyPulse 1104660
62Trolley EM 3/2105018
63Foot switch LW87593
64Foot switch BLE111629
65Skypulse (M321-B)101398
66Handpiece HC02-N90669
67Handpiece HC14-N90668
68Handpiece HC14-NS95734
69Handpiece HC14-NE103740
70Handpiece R1790039
71Handpiece R21-C390011
72Handpiece R24-S105629
73Handpiece Genova102631
74Handpiece MarcCo S104563
75Handpiece MarcCo M104283
76Handpiece MarcCo L104560
77Cylindrical Sapphire 1300/871766
78Cylindrical Sapphire 1300/1272558
79Conical Sapphire 600/872937
80Flat Chiseled 500/1272561
81Radial, Sweeps 400/1490333
82Radial, Sweeps 600/1490334
83Conical Sapphire 800/872560
84Conical Sapphire 800/1272856
85Flat Sweeps 300/2083890
86Flat Sweeps 400/1484827
87Flat Varian 500/1484837
88Flat Varian 600/984838
89Flat Varian 600/1484839
90Conical Sapphire 600/1099128
91Conical Sapphire 600/1272857
92Conical Sapphire 600/1685830
93Flat Sweeps 300/9102037
94Flat Sweeps 400/984826
95Radial Sweeps 400/9102036
96Flat Varian 500/984836
97Radial, Sweeps 600/9102135
98Thin Chisel 150/12110325
99Cylindrical Sapphire 1000/4112782
100Cylindrical Sapphire 1000/8112781
101Cylindrical Sapphire 1000/12112779
102Radial Sweeps 400/1490333
103Radial Sweeps 600/1490334
104Flat Sweeps 300/2083890
105Flat Sweeps 400/1484827
106Conical Sapphire 600/1099128
107Flat Sweeps 300/9102037
108Flat Sweeps 400/984826
109Radial Sweeps 400/9102036
110Radial, Sweeps 600/9102135
111Thin Chisel 150/12110325
112Cylindrical Sapphire 1000/4112782
113Cylindrical Sapphire 1000/8112781
114Laser module LM XS-A101468
115Laser module LM XS-B101469
116Laser module LM XS-C106020
117Laser module LM XS-AF110664
118Laser module LM XS-BF110665
119Laser module LM XS-CF110666
120Laser module LM XD-10102821
121Laser module LM XD-10/19102824
122Laser module LM XD-67/10102825
123Laser module LM XD-67/80/10F108970
124Trolley SkyPulse103240
125Trolley SkyPulse 1104660
126Trolley EM 3/2105018
127Foot switch LW87593
128Foot switch BLE111629
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