LV-H Series
| Model |
FDA Laser Class |
Accession No. |
| LV-H41/LV-11A(P) |
Laser Class I |
0020801-03 |
| LV-H32/LV-2x(A)(P) |
Laser Class 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 Class II |
0020801-05 |
| LV-H47/LV-2x(A)(P) |
Laser Class II |
0020801-06 |
| LV-H35/LV-2x(A)(P) |
Laser Class II |
0020801-07 |
| LV-H64/LV-2x(A)(P) |
Laser Class II |
0020801-08 |
| LV-H65/LV-2x(A)(P) |
| LV-H100/5x(M)(P) |
Laser Class II |
0020801-09 |
| LV-H100/2x(A)(P) |
| LV-H300/5x(M)(P) |
| LV-H300/2x(A)(P) |
| LV-H110/5x(M)(P) |
Laser Class II |
0020801-10 |
| LV-H110/2x(A)(P) |
| LV-H35F/LV-2x(A)(P) |
Laser Class II |
0020801-11 |
| LV-H62F/LV-2x(A)(P) |
GV-H Series
| Model |
FDA Laser Class |
Accession No. |
| GV-H45/GV-21(P) |
Laser Class 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 Class II |
0622664-01 |
| GV-H1000/GV-22(P) |
| GV-H45L/GV-21(P) |
Laser Class 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) |
LV-S Series
| Model |
FDA Laser Class |
Accession No. |
| LV-S71/LV-11S(P) |
Laser Class 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) |
|
|
SZ Series
| Model |
FDA Laser Class |
Accession No. |
| SZ-01S |
Laser Class 1
(Laser Notice No. 50) |
0820676-001 |
| SZ-04M |
| SZ-16V |
IG Series
| Model |
FDA Laser Class |
Accession No. |
| IG-010/IG-1000 |
Laser Class 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 |
FT Series
| Model |
FDA Laser Class |
Accession No. |
| FT-H10/FT-50(A)(W)(P) |
Laser Class 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) |
LB Series
| Model |
FDA Laser Class |
Accession No. |
| LB-11/LB-70 |
Laser Class IIIb |
8822033-02 |
| LB-11W/LB-70W |
8822033-03 |
| LB-12/LB-72 |
9020315-00 |
| LB-12W/LB-72W |
9020315-01 |
IA Series
| Model |
FDA Laser Class |
Accession No. |
| IA-030/IA-1000 |
Laser Class 1
(Laser Notice No. 50) |
0920520-001 |
| IA-065/IA-1000 |
Laser Class II |
| IA-100/IA-1000 |
IL Series
| Model |
FDA Laser Class |
Accession No. |
| IL-030/IL-1000 |
Laser Class 1
(Laser Notice No. 50) |
1020134-000 |
| IL-030/IL-1050 |
| IL-030/IL-1500 |
| IL-030/IL-1550 |
| IL-065/IL-1000 |
Laser Class 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 |
LB-1000 Series
| Model |
FDA Laser Class |
Accession No. |
| LB-041/LB-1001 |
Laser Class IIIa |
9220269-00 |
| LB-081/LB-1101 |
| LB-301/LB-1201 |
Laser Class IIIb |
| LB-043/LB-1003 |
Laser Class II |
9220269-02 |
| LB-083/LB-1103 |
| LB-041/LB-1001W |
Laser Class IIIa |
9220269-06 |
| LB-081/LB-1101W |
| LB-301/LB-1201W |
Laser Class IIIb |
9220269-06 |
|
| |
|
|
VG Series
| Model |
FDA Laser Class |
Accession No. |
| VG-036/VG-301 |
Laser Class II |
9120630-05 |
LK-G3000 Series
| Model |
FDA Laser Class |
Accession No. |
| LK-G30/LK-G3000(P) |
Laser Class IIIa |
0421750-00 |
| LK-G30/LK-G3001(P) |
| LK-G35/LK-G3000(P) |
| LK-G35/LK-G3001(P) |
| LK-G32/LK-G3000(P) |
Laser Class II |
| LK-G32/LK-G3001(P) |
| LK-G37/LK-G3000(P) |
| LK-G37/LK-G3001(P) |
| LK-G150/LK-G3000(P) |
Laser Class IIIa |
0421750-01 |
| LK-G150/LK-G3001(P) |
| LK-G155/LK-G3000(P) |
| LK-G155/LK-G3001(P) |
| LK-G152/LK-G3000(P) |
Laser Class II |
| LK-G152/LK-G3001(P) |
| LK-G157/LK-G3000(P) |
| LK-G157/LK-G3001(P) |
| LK-G10/LK-G3000(P) |
Laser Class II |
0421750-02 |
| LK-G10/LK-G3001(P) |
| LK-G15/LK-G3000(P) |
| LK-G15/LK-G3001(P) |
| LK-G80/LK-G3000(P) |
Laser Class IIIa |
0421750-03 |
| LK-G80/LK-G3001(P) |
| LK-G85/LK-G3000(P) |
| LK-G85/LK-G3001(P) |
| LK-G82/LK-G3000(P) |
Laser Class II |
| LK-G82/LK-G3001(P) |
| LK-G87/LK-G3000(P) |
| LK-G87/LK-G3001(P) |
| LK-G400/LK-G3000(P) |
Laser Class IIIa |
0421750-04 |
| LK-G400/LK-G3001(P) |
| LK-G405/LK-G3000(P) |
| LK-G405/LK-G3001(P) |
| LK-G402/LK-G3000(P) |
Laser Class II |
| LK-G402/LK-G3001(P) |
| LK-G407/LK-G3000(P) |
| LK-G407/LK-G3001(P) |
| LK-G500/LK-G3000(P) |
Laser Class IIIa |
| LK-G500/LK-G3001(P) |
| LK-G505/LK-G3000(P) |
| LK-G505/LK-G3001(P) |
| LK-G502/LK-G3000(P) |
Laser Class II |
| LK-G502/LK-G3001(P) |
| LK-G507/LK-G3000(P) |
| LK-G507/LK-G3001(P) |
|
|
LK-G5000 Series
| Model |
FDA Laser Class |
Accession No. |
| LK-H008(W)/LK-G5000(P)/LK-HA100 |
Laser Class II |
0920018-001 |
| LK-H008(W)/LK-G5001(P)/LK-HA100 |
| LK-H022(K)/LK-G5000(P)/LK-HA100 |
Laser Class 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 Class 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 Class 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 Class 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 Class 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 Class 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 Class IIIa |
0920018-002 |
| LK-H085/LK-G5001(P)/LK-HA100 |
| LK-H087/LK-G5000(P)/LK-HA100 |
Laser Class II |
| LK-H087/LK-G5001(P)/LK-HA100 |
| LK-H155/LK-G5000(P)/LK-HA100 |
Laser Class IIIa |
| LK-H155/LK-G5001(P)/LK-HA100 |
| LK-H157/LK-G5000(P)/LK-HA100 |
Laser Class II |
| LK-H157/LK-G5001(P)/LK-HA100 |
|
| |
|
|
LT-9000 Series
| Model |
FDA Laser Class |
Accession No. |
| LT-9010/LT-9000 |
Laser Class 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 |
LJ-G Series
| Model |
FDA Laser Class |
Accession No. |
| LJ-G080/LJ-G5000(P) |
Laser Class 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) |
LK Series
| Model |
FDA Laser Class |
Accession No. |
| LK-031/LK-2001 |
Laser Class II |
9220269-11 |
| LK-081/LK-2101 |
| LK-036/LK-2011 |
Laser Class II |
9220269-15 |
| LK-086/LK-2111 |
| LK-501/LK-2501 |
Laser Class IIIb |
9820951-01 |
| LK-503/LK-2503 |
Laser Class II |
| LK-011/LK-3101 |
Laser Class II |
9922844-00 |
LS-3000 Series
| Model |
FDA Laser Class |
Accession No. |
| LS-3032/LS-3100 |
Laser Class I |
9120541-02 |
| LS-3033/LS-3100 |
| LS-3033so(8073)/LS-3100 |
| LS-3034/LS-3100 |
| LS-3032/LS-3100W |
Laser Class I |
9120541-04 |
| LS-3033/LS-3100W |
| LS-3033so(8073)/LS-3100W |
| LS-3034/LS-3100W |
| LS-3036/LS-3100 |
Laser Class II |
9022020-02 |
| LS-3060/LS-3100 |
Laser Class II |
9022020-03 |
LS-5000 Series
| Model |
FDA Laser Class |
Accession No. |
| LS-5041/LS-5001 |
Laser Class II |
9120541-06 |
| LS-5041/LS-5501 |
| LS-5121/LS-5001 |
Laser Class II |
9120541-07 |
| LS-5121/LS-5501 |
BL-700 Series
| Model |
FDA Laser Class |
Accession No. |
| BL-700 |
Laser Class II |
9521135-03 |
| BL-701 |
| BL-780 |
| BL-781 |
| BL-740 |
9521135-04 |
| BL-741 |
BL-600 Series
| Model |
FDA Laser Class |
Accession No. |
| BL-600 |
Laser Class II |
9521135-12 |
| BL-601 |
| BL-600HA |
| BL-601HA |
| BL-650HA |
| BL-651HA |
|
|
BL-1300 Series
| Model |
FDA Laser Class |
Accession No. |
| BL-1300 |
Laser Class 2 |
0820248-000 |
| BL-1301 |
| BL-1300HA |
| BL-1301HA |
| BL-1350HA |
| BL-1351HA |
| BL-1370 |
| BL-1371 |
BL-N70 Series
| Model |
FDA Laser Class |
Accession No. |
| BL-N70V(E) |
Laser Class I |
9521135-13 |
| BL-N70UB(E) |
| BL-N70R(E) |
| BL-N70RK(E) |
SR-500 Series
| Model |
FDA Laser Class |
Accession No. |
| SR-500 |
Laser Class 1
(Laser Notice No. 50) |
0622041-00 |
| SR-510 |
SR-600 Series
| Model |
FDA Laser Class |
Accession No. |
| SR-600 |
Laser Class 1
(Laser Notice No. 50) |
0920493-000 |
| SR-600HA |
| SR-610 |
ML-G9300F Series
| Model |
FDA Laser Class |
Accession No. |
| ML-G9310F/ML-G9300F |
Laser for Marking
Laser Class IV
Laser for Guide
Laser Class 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 |
MD-F3000 Series
| Model |
FDA Laser Class |
Accession No. |
| MD-F3000(W) |
Laser Class 4
(Laser Notice No. 50) |
0920355-000 |
| MD-F3020(W) |
| MC-P1 |
ML-Z9500 Series
| Model |
FDA Laser Class |
Accession No. |
| ML-Z9510(W)/ML-Z9500(W) |
Laser for Marking
Laser Class IV
Laser for Guide
Laser Class 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 |
VK-8700 Series
| Model |
FDA Laser Class |
Accession No. |
| VK-8710K/8700K |
Laser Class II |
0622486-00 |
VK-9700 Series
| Model |
FDA Laser Class |
Accession No. |
| VK-9710K/9700K |
Laser Class II |
0622587-00 |
MD-V9900F Series
| Model |
FDA Laser Class |
Accession No. |
| MD-V9900F |
Laser for Marking
Laser Class IV
Laser for Guide
Laser Class II |
0720827-000 |
| MD-V9910F |
| MD-V9920F |
| MC-P1 |
| MD-V9900FA |
Laser for Marking
Laser Class IV
Laser for Guide
Laser Class II |
0720827-002 |
| MD-V9910FA |
| MD-V9920FA |
| MC-P1 |
MD-H9800W Series
| Model |
FDA Laser Class |
Accession No. |
| MD-H9810W/MD-H9800W |
Laser Class IV |
0422793-01 |
| MD-H9820W/MD-H9800W |
|
Outline of FDA (CDRH)
FDA (Food and Drug Administration), one of the U.S. government agency, oversees many smaller organizations. One of those organizations is known as the CDRH (Center for Devices and Radiological Health), which is responsible for radiological electrical products and medical devices. Products using lasers are controlled by the CDRH.
21 CFR Part 1040.10 provides specific safety standards for laser products. Products that do not comply with these standards cannot be sold in the U.S., nor can they be imported into the U.S.
