Lightlas Model 532
510(k) K091534
Lightlas Model 532 is a medical device (FDA Class II; FDA product code HQF, Laser, Ophthalmic) made by Lightmed Corporation, cleared under FDA 510(k) K091534 on 18 Sep 2009, active as of 13 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK091534 | Date18 Sep 2009 | StatusActive |
Official records
- FDA 510(k) database K091534
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HQF
- FDA applicant
- Lightmed Corp.
- Device class
- Class II
- Regulation
- 21 CFR Part 886.4390
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K091534
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| LightLas 532 LC0013(3W) | LC0013(3W) | 04712826770604 | Weight 20 kg | On the market |
| LightLas 532 LC0014(5W) | LC0014(5W) | 04712826770895 | On the market |
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