Who else makes this device?

Name: PDT Laser (Vpdt)
Brand: PDT Laser (Vpdt)

Ophthalmic › DiagnosticLens, Fundus, Hruby, Diagnostic

PDT Laser (Vpdt)

PDT Laser (Vpdt): 1 catalogue number listed by Volk Optical Inc., United States, under Lens, Fundus, Hruby, Diagnostic. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1recall

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code HJI
Manufacturer	City	Province	Registered as	Device types
Beijing Hongdee Corporation	Beijing	Beijing	Private-label distributor	43

Record

Regulatory record for PDT Laser (Vpdt)
Listed by	Volk Optical Inc., United States
FDA product code	HJI
Device type	Lens, Fundus, Hruby, Diagnostic
Device class	Class 1
Regulation	21 CFR 886.1395
Establishment	Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2016-09-29
Record revised	2020-09-30 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for PDT Laser (Vpdt)
Catalogue number	Size	Status
VPDT		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Heine Omega 180	Sontec Instruments, Inc.	2
Alcon Grieshaber	Alcon Laboratories, Inc.	1
TransEquator (VTE)	Volk Optical Inc.	1

Recalls

1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2015-02-27	Class III	Other	Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error.	78 units	2016-02-04

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.