Quantel Medical: FDA filings under this applicant name

FDA lists 31 510(k) clearances under 2 spellings of the applicant name “Quantel Medical” (first 2000, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 100 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Quantel Medical took a median 100 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.

Top product codes

Review panels

• Ophthalmic (13)
• General and Plastic Surgery (10)
• Radiology (8)

Most recent Quantel Medical 510(k) clearances

21 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Quantel Medical.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Quantel Medical is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT06349356: Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease" (Completed, started 2023-03-28)

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Quantel Medical (30)
• Quantel Medical, Inc. (1)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Quantel Derma GmbH (2 510(k)s)
• Quantel Medical S.A. (2 510(k)s)
• Quantel S.A. (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Quantel Medical?

FDA lists 31 510(k) clearances under 2 spellings of the applicant name “Quantel Medical” (first 2000, latest 2026), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Quantel Medical?

The median time from FDA receipt to decision across 510(k)s cleared under the name Quantel Medical is 90 days. Since 2017: 100 days, versus 91 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Quantel Medical?

The most frequent FDA product codes under this applicant name are HQF (Laser, Ophthalmic, 13); GEX (Powered Laser Surgical Instrument, 9); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 8).

Next steps

• See all 31 Quantel Medical clearances with predicates and recalls
• Run predicate analysis for product code HQF, Quantel Medical's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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