Modellreihe LV-H
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| LV-H41/LV-11A(P) |
Laser Klasse I |
0020801-03 |
| LV-H32/LV-2x(A)(P) |
Laser Klasse II |
0020801-03 |
| LV-H42/LV-2x(A)(P) |
| LV-H37/LV-2x(A)(P) |
| LV-H62/LV-2x(A)(P) |
| LV-H67/LV-2x(A)(P) |
Laser Klasse II |
0020801-05 |
| LV-H47/LV-2x(A)(P) |
Laser Klasse II |
0020801-06 |
| LV-H35/LV-2x(A)(P) |
Laser Klasse II |
0020801-07 |
| LV-H64/LV-2x(A)(P) |
Laser Klasse II |
0020801-08 |
| LV-H65/LV-2x(A)(P) |
| LV-H100/5x(M)(P) |
Laser Klasse II |
0020801-09 |
| LV-H100/2x(A)(P) |
| LV-H300/5x(M)(P) |
| LV-H300/2x(A)(P) |
| LV-H110/5x(M)(P) |
Laser Klasse II |
0020801-10 |
| LV-H110/2x(A)(P) |
| LV-H35F/LV-2x(A)(P) |
Laser Klasse II |
0020801-11 |
| LV-H62F/LV-2x(A)(P) |
Modellreihe GV-H
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| GV-H45/GV-21(P) |
Laser Klasse II |
0622664-00 |
| GV-H45/GV-22(P) |
| GV-H130/GV-21(P) |
| GV-H130/GV-22(P) |
| GV-H450/GV-21(P) |
| GV-H450/GV-22(P) |
| GV-H1000/GV-21(P) |
Laser Klasse II |
0622664-01 |
| GV-H1000/GV-22(P) |
| GV-H45L/GV-21(P) |
Laser Klasse 1
(Laser Notice No. 50) |
0622664-002 |
| GV-H45L/GV-22(P) |
| GV-H130L/GV-21(P) |
| GV-H130L/GV-22(P) |
| GV-H450L/GV-21(P) |
| GV-H450L/GV-22(P) |
| GV-H1000L/GV-21(P) |
| GV-H1000L/GV-22(P) |
Modellreihe LV-S
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| LV-S71/LV-11S(P) |
Laser Klasse 1
(Laser Notice No. 50) |
0520365-00 |
| LV-S71/LV-12S(P) |
| LV-S41/LV-11S(P) |
| LV-S41/LV-12S(P) |
| LV-S72/LV-11S(P) |
0520365-01 |
| LV-S72/LV-12S(P) |
| LV-S31/LV-11SA(P) |
0520365-02 |
| LV-S31/LV-12SA(P) |
| LV-S41(L)/LV-11SA(P) |
| LV-S41(L)/LV-12SA(P) |
| LV-S61/LV-11SA(P) |
| LV-S61/LV-12SA(P) |
| LV-S71/LV-11SA(P) |
| LV-S71/LV-12SA(P) |
| LV-S72/LV-11SA(P) |
| LV-S72/LV-12SA(P) |
| LV-S31/LV-11SB(P) |
0520365-03 |
| LV-S31/LV-12SB(P) |
| LV-S41(L)/LV-11SB(P) |
| LV-S41(L)/LV-12SB(P) |
| LV-S61/LV-11SB(P) |
| LV-S61/LV-12SB(P) |
| LV-S62/LV-11SB(P) |
| LV-S62/LV-12SB(P) |
| LV-S63/LV-11SB(P) |
| LV-S63/LV-12SB(P) |
| LV-S71/LV-11SB(P) |
| LV-S71/LV-12SB(P) |
| LV-S72/LV-11SB(P) |
| LV-S72/LV-12SB(P) |
|
|
Modellreihe SZ
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| SZ-01S |
Laser Klasse 1
(Laser Notice No. 50) |
0820676-001 |
| SZ-04M |
| SZ-16V |
Modellreihe IG
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| IG-010/IG-1000 |
Laser Klasse 1
(Laser Notice No. 50) |
0920516-000 |
| IG-010/IG-1050 |
| IG-010/IG-1500 |
| IG-010/IG-1550 |
| IG-028/IG-1000 |
| IG-028/IG-1050 |
| IG-028/IG-1500 |
| IG-028/IG-1550 |
Modellreihe FT
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| FT-H10/FT-50(A)(W)(P) |
Laser Klasse 1
(Laser Notice No. 50) |
0520768-001 |
| FT-H10/FT-55(A)(W)(P) |
| FT-H20/FT-50(A)(W)(P) |
| FT-H20/FT-55(A)(W)(P) |
| FT-H30/FT-50(A)(W)(P) |
| FT-H30/FT-55(A)(W)(P) |
| FT-H40K/FT-50(A)(W)(P) |
| FT-H40K/FT-55(A)(W)(P) |
| FT-H50/FT-50(A)(W)(P) |
| FT-H50/FT-55(A)(W)(P) |
| FT-H50K/FT-50(A)(W)(P) |
| FT-H50K/FT-55(A)(W)(P) |
Modellreihe LB
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| LB-11/LB-70 |
Laser Klasse IIIb |
8822033-02 |
| LB-11W/LB-70W |
8822033-03 |
| LB-12/LB-72 |
9020315-00 |
| LB-12W/LB-72W |
9020315-01 |
Modellreihe IA
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| IA-030/IA-1000 |
Laser Klasse 1
(Laser Notice No. 50) |
0920520-001 |
| IA-065/IA-1000 |
Laser Klasse II |
| IA-100/IA-1000 |
Modellreihe IL
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| IL-030/IL-1000 |
Laser Klasse 1
(Laser Notice No. 50) |
1020134-000 |
| IL-030/IL-1050 |
| IL-030/IL-1500 |
| IL-030/IL-1550 |
| IL-065/IL-1000 |
Laser Klasse 2
(Laser Notice No. 50) |
| IL-065/IL-1050 |
| IL-065/IL-1500 |
| IL-065/IL-1550 |
| IL-100/IL-1000 |
| IL-100/IL-1050 |
| IL-100/IL-1500 |
| IL-100/IL-1550 |
Modellreihe LB-1000
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| LB-041/LB-1001 |
Laser Klasse IIIa |
9220269-00 |
| LB-081/LB-1101 |
| LB-301/LB-1201 |
Laser Klasse IIIb |
| LB-043/LB-1003 |
Laser Klasse II |
9220269-02 |
| LB-083/LB-1103 |
| LB-041/LB-1001W |
Laser Klasse IIIa |
9220269-06 |
| LB-081/LB-1101W |
| LB-301/LB-1201W |
Laser Klasse IIIb |
9220269-06 |
|
| |
|
|
Modellreihe VG
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| VG-036/VG-301 |
Laser Klasse II |
9120630-05 |
Modellreihe LK-G3000
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| LK-G30/LK-G3000(P) |
Laser Klasse IIIa |
0421750-00 |
| LK-G30/LK-G3001(P) |
| LK-G35/LK-G3000(P) |
| LK-G35/LK-G3001(P) |
| LK-G32/LK-G3000(P) |
Laser Klasse II |
| LK-G32/LK-G3001(P) |
| LK-G37/LK-G3000(P) |
| LK-G37/LK-G3001(P) |
| LK-G150/LK-G3000(P) |
Laser Klasse IIIa |
0421750-01 |
| LK-G150/LK-G3001(P) |
| LK-G155/LK-G3000(P) |
| LK-G155/LK-G3001(P) |
| LK-G152/LK-G3000(P) |
Laser Klasse II |
| LK-G152/LK-G3001(P) |
| LK-G157/LK-G3000(P) |
| LK-G157/LK-G3001(P) |
| LK-G10/LK-G3000(P) |
Laser Klasse II |
0421750-02 |
| LK-G10/LK-G3001(P) |
| LK-G15/LK-G3000(P) |
| LK-G15/LK-G3001(P) |
| LK-G80/LK-G3000(P) |
Laser Klasse IIIa |
0421750-03 |
| LK-G80/LK-G3001(P) |
| LK-G85/LK-G3000(P) |
| LK-G85/LK-G3001(P) |
| LK-G82/LK-G3000(P) |
Laser Klasse II |
| LK-G82/LK-G3001(P) |
| LK-G87/LK-G3000(P) |
| LK-G87/LK-G3001(P) |
| LK-G400/LK-G3000(P) |
Laser Klasse IIIa |
0421750-04 |
| LK-G400/LK-G3001(P) |
| LK-G405/LK-G3000(P) |
| LK-G405/LK-G3001(P) |
| LK-G402/LK-G3000(P) |
Laser Klasse II |
| LK-G402/LK-G3001(P) |
| LK-G407/LK-G3000(P) |
| LK-G407/LK-G3001(P) |
| LK-G500/LK-G3000(P) |
Laser Klasse IIIa |
| LK-G500/LK-G3001(P) |
| LK-G505/LK-G3000(P) |
| LK-G505/LK-G3001(P) |
| LK-G502/LK-G3000(P) |
Laser Klasse II |
| LK-G502/LK-G3001(P) |
| LK-G507/LK-G3000(P) |
| LK-G507/LK-G3001(P) |
|
|
Modellreihe LK-G5000
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| LK-H008(W)/LK-G5000(P)/LK-HA100 |
Laser Klasse II |
0920018-001 |
| LK-H008(W)/LK-G5001(P)/LK-HA100 |
| LK-H022(K)/LK-G5000(P)/LK-HA100 |
Laser Klasse II |
0920018-000 |
| LK-H022(K)/LK-G5001(P)/LK-HA100 |
| LK-H027(K)/LK-G5000(P)/LK-HA100 |
| LK-H027(K)/LK-G5001(P)/LK-HA100 |
| LK-H020/LK-G5000(P)/LK-HA100 |
Laser Klasse IIIa |
| LK-H020/LK-G5001(P)/LK-HA100 |
| LK-H025/LK-G5000(P)/LK-HA100 |
| LK-H025/LK-G5001(P)/LK-HA100 |
| LK-H023/LK-G5000(P)/LK-HA100 |
Laser Klasse IIIb |
| LK-H023/LK-G5001(P)/LK-HA100 |
| LK-H028/LK-G5000(P)/LK-HA100 |
| LK-H028/LK-G5001(P)/LK-HA100 |
| LK-H052(K)/LK-G5000(P)/LK-HA100 |
Laser Klasse II |
| LK-H052(K)/LK-G5001(P)/LK-HA100 |
| LK-H057(K)/LK-G5000(P)/LK-HA100 |
| LK-H057(K)/LK-G5001(P)/LK-HA100 |
| LK-H050/LK-G5000(P)/LK-HA100 |
Laser Klasse IIIa |
| LK-H050/LK-G5001(P)/LK-HA100 |
| LK-H055/LK-G5000(P)/LK-HA100 |
| LK-H055/LK-G5001(P)/LK-HA100 |
| LK-H053/LK-G5000(P)/LK-HA100 |
Laser Klasse IIIb |
| LK-H053/LK-G5001(P)/LK-HA100 |
| LK-H058/LK-G5000(P)/LK-HA100 |
| LK-H058/LK-G5001(P)/LK-HA100 |
| LK-H085/LK-G5000(P)/LK-HA100 |
Laser Klasse IIIa |
0920018-002 |
| LK-H085/LK-G5001(P)/LK-HA100 |
| LK-H087/LK-G5000(P)/LK-HA100 |
Laser Klasse II |
| LK-H087/LK-G5001(P)/LK-HA100 |
| LK-H155/LK-G5000(P)/LK-HA100 |
Laser Klasse IIIa |
| LK-H155/LK-G5001(P)/LK-HA100 |
| LK-H157/LK-G5000(P)/LK-HA100 |
Laser Klasse II |
| LK-H157/LK-G5001(P)/LK-HA100 |
|
| |
|
|
Modellreihe LT-9000
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| LT-9010/LT-9000 |
Laser Klasse IIa |
0322254-00 |
| LT-9011/LT-9000 |
| LT-9010M/LT-9500 |
| LT-9011M/LT-9500 |
| LT-9010/LT-9001 |
| LT-9011/LT-9001 |
| LT-9010M/LT-9501 |
| LT-9011M/LT-9501 |
| LT-9030/LT-9001 |
0322254-01 |
| LT-9031/LT-9001 |
| LT-9030M/LT-9501 |
| LT-9031M/LT-9501 |
Modellreihe LJ-G
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| LJ-G080/LJ-G5000(P) |
Laser Klasse II |
0622562-00 |
| LJ-G080/LJ-G5001(P) |
| LJ-G030/LJ-G5000(P) |
0622562-01 |
| LJ-G030/LJ-G5001(P) |
| LJ-G200/LJ-G5000(P) |
| LJ-G200/LJ-G5001(P) |
| LJ-G015/LJ-G5000(P) |
0622562-02 |
| LJ-G015/LJ-G5001(P) |
| LJ-G015K/LJ-G5000(P) |
| LJ-G015K/LJ-G5001(P) |
Modellreihe LK
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| LK-031/LK-2001 |
Laser Klasse II |
9220269-11 |
| LK-081/LK-2101 |
| LK-036/LK-2011 |
Laser Klasse II |
9220269-15 |
| LK-086/LK-2111 |
| LK-501/LK-2501 |
Laser Klasse IIIb |
9820951-01 |
| LK-503/LK-2503 |
Laser Klasse II |
| LK-011/LK-3101 |
Laser Klasse II |
9922844-00 |
Modellreihe LS-3000
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| LS-3032/LS-3100 |
Laser Klasse I |
9120541-02 |
| LS-3033/LS-3100 |
| LS-3033so(8073)/LS-3100 |
| LS-3034/LS-3100 |
| LS-3032/LS-3100W |
Laser Klasse I |
9120541-04 |
| LS-3033/LS-3100W |
| LS-3033so(8073)/LS-3100W |
| LS-3034/LS-3100W |
| LS-3036/LS-3100 |
Laser Klasse II |
9022020-02 |
| LS-3060/LS-3100 |
Laser Klasse II |
9022020-03 |
Modellreihe LS-5000
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| LS-5041/LS-5001 |
Laser Klasse II |
9120541-06 |
| LS-5041/LS-5501 |
| LS-5121/LS-5001 |
Laser Klasse II |
9120541-07 |
| LS-5121/LS-5501 |
Modellreihe BL-700
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| BL-700 |
Laser Klasse II |
9521135-03 |
| BL-701 |
| BL-780 |
| BL-781 |
| BL-740 |
9521135-04 |
| BL-741 |
Modellreihe BL-600
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| BL-600 |
Laser Klasse II |
9521135-12 |
| BL-601 |
| BL-600HA |
| BL-601HA |
| BL-650HA |
| BL-651HA |
|
|
Modellreihe BL-1300
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| BL-1300 |
Laser Klasse 2
（Laser Notice No.50） |
0820248-000 |
| BL-1301 |
| BL-1300HA |
| BL-1301HA |
| BL-1350HA |
| BL-1351HA |
| BL-1370 |
| BL-1371 |
Modellreihe BL-N70
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| BL-N70V(E) |
Laser Klasse 1
(Laser Notice No.50)
|
9521135-13 |
| BL-N70UB(E) |
| BL-N70R(E) |
| BL-N70RK(E) |
Modellreihe SR-500
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| SR-500 |
Laser Klasse 1
(Laser Notice No. 50) |
0622041-00 |
| SR-510 |
Modellreihe SR-600
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| SR-600 |
Laser Klasse 1
(Laser Notice No. 50) |
0920493-000 |
| SR-600HA |
| SR-610 |
Modellreihe ML-G9300F
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| ML-G9310F/ML-G9300F |
Markierungslaser
Laser Klasse IV
Führungslaser
Laser Klasse II |
0320653-02 |
| ML-G9311F/ML-G9300F |
| ML-G9320F/ML-G9300F |
| ML-G9321F/ML-G9300F |
| ML-G9370F/ML-G9300F |
| ML-G9371F/ML-G9300F |
| ML-G9310T/ML-G9300F |
| ML-GP1F |
| MC-P1 |
Modellreihe MD-F3000
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| MD-F3000(W) |
Laser Klasse 4
(Laser Notice No. 50) |
0920355-000 |
| MD-F3020(W) |
| MC-P1 |
Modellreihe ML-Z9500
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| ML-Z9510(W)/ML-Z9500(W) |
Markierungslaser
Laser Klasse IV
Führungslaser
Laser Klasse II |
0622252-004 |
| ML-Z9520(W)/ML-Z9500(W) |
| ML-Z9550(W)/ML-Z9500(W) |
| ML-Z9510T(W)/ML-Z9500(W) |
| ML-Z9520T(W)/ML-Z9500(W) |
| ML-Z9550T(W)/ML-Z9500(W) |
| ML-ZP1 |
| MC-P1 |
Modellreihe VK-8700
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| VK-8710K/8700K |
Laser Klasse II |
0622486-00 |
Modellreihe VK-9700
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| VK-9.710K/9.700K |
Laser Klasse II |
0622587-00 |
Modellreihe MD-V9900F
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| MD-V9900F |
Markierungslaser
Laser Klasse IV
Führungslaser
Laser Klasse II |
0720827-000 |
| MD-V9910F |
| MD-V9920F |
| MC-P1 |
| MD-V9900FA |
Markierungslaser
Laser Klasse IV
Führungslaser
Laser Klasse II |
0720827-002 |
| MD-V9910FA |
| MD-V9920FA |
| MC-P1 |
Modellreihe MD-H9800W
| Modell |
FDA-Laser Klasse |
Zugangsnr. |
| MD-H9810W/MD-H9800W |
Laser Klasse IV |
0422793-01 |
| MD-H9820W/MD-H9800W |
|
Kurze Beschreibung der FDA (CDRH)
Die US-Regierungsbehöre FDA (Food and Drug Administration) überwacht mehrere kleinere Organisationen. Zu diesen Organisationen gehört das CDRH (Center for Devices and Radiological Health), das für elektrische Röntgengeräte und medizinische Geräte zuständig ist. Produkte, die Laser verwenden, werden vom CDRH überwacht. In 21 CFR Teil 1040.10 werden spezifische Sicherheitsnormen für Lasergeräte aufgeführt. Geräte, die diese Normen nicht erfüllen, können in den USA weder verkauft noch in die USA eingeführt werden.
